Clinical trial • Phase III • Oncology

CISPLATIN for Hepatoblastoma | Hepatocellular carcinoma

Phase III trial of CISPLATIN for Hepatoblastoma | Hepatocellular carcinoma.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Hepatoblastoma | Hepatocellular carcinoma
Trial Stage: Phase III
Drug Modality: Small molecule
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 15-10-2024
First CTIS Authorization Date: 21-01-2025

Trial design

Randomised, open-label, group b1: 2 cycles vs 4 cycles of post-operative chemotherapy (cisplatin-based as per protocol). group c randomisation (three arms): (i) cisplatin/5-fluorouracil/vincristine/doxorubicin (c5vd); (ii) siopel-3 high-risk chemotherapy with cisplatin, carboplatin and doxorubicin (siopel-3hr); (iii) dose-compressed cisplatin monotherapy (cddp-m). group d2 randomisation: carboplatin+doxorubicin (cd) alternating with carboplatin+etoposide (ce) versus cd alternating with vincristine+irinotecan (vi). group f randomisation: plado + sorafenib versus plado + sorafenib / gemox + sorafenib. (doses and detailed schedules not specified in the ctis summary.)-controlled Phase III trial across 91 sites in Austria, Belgium, Czechia and others.

Randomised: Yes
Open Label: Yes
Comparator: Group B1: 2 cycles vs 4 cycles of post-operative chemotherapy (cisplatin-based as per protocol). Group C randomisation (three arms): (i) cisplatin/5-fluorouracil/vincristine/doxorubicin (C5VD); (ii) SIOPEL-3 high-risk chemotherapy with cisplatin, carboplatin and doxorubicin (SIOPEL-3HR); (iii) dose-compressed cisplatin monotherapy (CDDP-M). Group D2 randomisation: carboplatin+doxorubicin (CD) alternating with carboplatin+etoposide (CE) versus CD alternating with vincristine+irinotecan (VI). Group F randomisation: PLADO + Sorafenib versus PLADO + Sorafenib / GEMOX + Sorafenib. (Doses and detailed schedules not specified in the CTIS summary.)
Target Sample Size: 157

Eligibility

Recruits 157 paediatric patients.

Pregnancy Exclusion: • Pregnant or breastfeeding women
Vulnerable Population: Children and adolescents are included (paediatric trial). Written informed consent is required; age-specific subject information and consent/assent forms are provided (multiple documents for parents/guardians and for patients grouped by age: e.g. child, adolescent, 16+, 18+ versions). Assent and parental/guardian consent procedures are specified in the supplied ICF documents; for allocation/randomisation written informed consent is required and females of child-bearing potential require a negative pregnancy test and agreement to use contraception during the trial.

Inclusion criteria

{"criterion_text":"- General criteria • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: a) The patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy. b) There is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.). c) Uncorrectable coagulopathy."}
{"criterion_text":"- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age"}
{"criterion_text":"- General criteria • Age ≤30 years"}
{"criterion_text":"- Group D • Patient meets High Risk definition according to CHIC Guidelines"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}
{"criterion_text":"- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age"}
{"criterion_text":"- Group E - At diagnosis: • Patient has been diagnosed with HCC"}
{"criterion_text":"- • Tumour has been resected with negative margins Group E1"}
{"criterion_text":"- • HCC secondary to underlying liver disease"}
{"criterion_text":"- Group A2\t- Treatment arm • Central pathology review confirming non-WDF histology."}
{"criterion_text":"- Group E2 • HCC de novo, including fibrolamellar"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}
{"criterion_text":"- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method"}
{"criterion_text":"- General criteria • Written informed consent for trial entry"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age"}
{"criterion_text":"- Group F • Patient diagnosed with HCC"}
{"criterion_text":"- • Tumour locally assessed as un-resectable, or metastatic HCC disease"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}
{"criterion_text":"- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age o Qt/QTc interval =/<450msec for males, =/<470msec for females"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}
{"criterion_text":"- For Allocation/Randomisation to Treatment Group: All Groups • Written Informed Consent for trial treatment participation"}
{"criterion_text":"- For Allocation/Randomisation to Treatment Group: All Groups • Patient assessed as fit to receive group specific treatment"}
{"criterion_text":"- For Allocation/Randomisation to Treatment Group: All Groups • For females of child-bearing potential, a negative pregnancy test prior to trial entry is required. Any patient who is of reproductive age must agree to use adequate contraception for the duration of the trial."}
{"criterion_text":"- Group A (no treatment arm) - At diagnosis: • Resected Tumour."}
{"criterion_text":"- Group A1 – No treatment arm • Patient meets Very Low Risk definition according to CHIC guidelines."}
{"criterion_text":"- Group A1 – No treatment arm • Central pathology review confirming WDF histology."}
{"criterion_text":"- Groups B, C & D - Real time review required if age>8 and/or AFP<100 – confirm HB diagnosis"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age"}
{"criterion_text":"- Group B\t • Patient meets Low Risk definition according to CHIC Guidelines"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}
{"criterion_text":"- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age"}
{"criterion_text":"- Group C • Patient meets Intermediate Risk definition according to CHIC Guidelines"}
{"criterion_text":"- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2"}

Exclusion criteria

{"criterion_text":"- • Any previous chemotherapy or currently receiving anti-cancer agents"}
{"criterion_text":"- • Concomitant use with St John’s Wort which cannot be stopped prior to start of trial treatment"}
{"criterion_text":"- Group F: • Peripheral Sensitive Neuropathy with functional impairment"}
{"criterion_text":"- • Personal or family history of congenital long QT syndrome"}
{"criterion_text":"- • QT/QTc interval >450msec for men and >470msec for women (corrected measurement of QT according to BAZETT formula)"}
{"criterion_text":"- • Patients who are unable to swallow tablets , where an oral solution is not available or approved"}
{"criterion_text":"- • Recurrent disease"}
{"criterion_text":"- • Previously received a solid organ transplant"}
{"criterion_text":"- • Uncontrolled infection"}
{"criterion_text":"- • Unable to follow the protocol for any reason"}
{"criterion_text":"- • Second malignancy"}
{"criterion_text":"- • Pregnant or breastfeeding women"}
{"criterion_text":"- Treatment Group Specific Exclusion Criteria Group C: • Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)"}
{"criterion_text":"- Group D: • Chronic inflammatory bowel disease and/or bowel obstruction"}

Endpoints

Primary endpoints

{"endpoint_text":"- Event Free Survival (EFS) as defined as the time from randomisation (or registration into the trial for non-randomised patients) to the first failure event. Patients who have not had an event will be censored at their last follow-up date.","definition_or_measurement_approach":"Defined as time from randomisation (or registration for non-randomised patients) to first failure event; censoring at last follow-up for patients without event."}
{"endpoint_text":"- Progression of existing disease or occurrence of disease at new sites","definition_or_measurement_approach":""}
{"endpoint_text":"- Death from any cause prior to disease progression","definition_or_measurement_approach":""}
{"endpoint_text":"- Diagnosis of a second malignant neoplasm.","definition_or_measurement_approach":""}
{"endpoint_text":"- Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria. The assessment will be performed after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOx+S in Group F patients. Patients who are not assessable for response, e.g. because of early stopping of treatment or death, will be assumed to be non-responders.","definition_or_measurement_approach":"Response assessed by RECIST v1.1 (CR/PR). Assessment timing: after 3 cycles of PLADO or 4 cycles of PLADO+S/GEMOx+S in Group F; non-assessable patients counted as non-responders."}

Secondary endpoints

{"endpoint_text":"- Failure-free survival (FFS): defined as per EFS (above) with the addition of failure to go to resection.","definition_or_measurement_approach":"Defined as EFS with addition of failure to proceed to resection."}
{"endpoint_text":"- Overall survival (OS): defined as the time from randomisation (or enrolment for non-randomised patients) to death from any cause. Patients who have not died will be censored at their last follow-up date.","definition_or_measurement_approach":"Time from randomisation/enrolment to death from any cause; censoring at last follow-up for survivors."}
{"endpoint_text":"- Toxicity will be recorded in relation to each cycle of randomised treatment and will be categorised and graded using Common Terminology Criteria for Adverse Events (CTCAE)","definition_or_measurement_approach":"Toxicity recorded per cycle and graded using CTCAE."}
{"endpoint_text":"- Chemotherapy-related cardiac, nephro- and oto- toxicity will be recorded in relation to each cycle of non-randomised treatment and will be categorised and graded using common terminology criteria for adverse events (CTCAE)","definition_or_measurement_approach":"Cardiac, renal and ototoxicity recorded per cycle and graded using CTCAE."}
{"endpoint_text":"- Hearing loss will be measured according to the SIOP Boston Scale for oto-toxicity. The assessment will be performed at end of treatment and follow up.","definition_or_measurement_approach":"Hearing loss measured with SIOP Boston Scale at end of treatment and during follow-up."}
{"endpoint_text":"- Best Response as defined as Complete Response (CR) and Progressive Response (PR) and is defined in the protocol (Appendix 8) based on radiological response and AFP decline. Best response will be measured throughout treatment period and follow up. Patients who are not assessable for response , e.g. because of early stopping of treatment or death - will be assumed non-responders","definition_or_measurement_approach":"Best response per protocol Appendix 8 using radiology and AFP decline; non-assessable patients assumed non-responders."}
{"endpoint_text":"- Surgical resectability as defined as complete resection, partial resection or transplant following randomisation (or enrolment for non-randomised patients).","definition_or_measurement_approach":"Resectability categorized as complete resection, partial resection or transplant following randomisation/enrolment."}

Recruitment

Planned Sample Size: 157
Recruitment Window Months: 38
Consent Approach: Written informed consent is required. Age-specific information and consent/assent forms are provided for different age groups (multiple ICF/PIS documents for children and adolescents, parents/guardians, and adults). For minors, parental/guardian consent and child assent (as applicable by age) are used; separate versions exist for child, adolescent and adult participants. For allocation/randomisation, written informed consent for trial treatment participation is required. Females of child-bearing potential must have a negative pregnancy test and agree to use adequate contraception for trial duration. Documents are available in multiple country/language versions (English, French, Dutch, Czech, Polish, German, Norwegian, Spanish as indicated by provided ICF/PIS documents).

Geography

Total Number Of Sites: 91
Total Number Of Participants: 292

Austria

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 27-01-2025
Processing Time Days: 88
Number Of Sites: 5
Number Of Participants: 11

Sites

Site Name: St. Anna Kinderspital GmbH
Department Name: 2b
Principal Investigator Name: Heidrun Boztug
Principal Investigator Email: Heidrun.boztug@stanna.at
Contact Person Name: Heidrun Boztug
Contact Person Email: Heidrun.boztug@stanna.at

Site Name: Medizinische Universitaet Innsbruck
Department Name: Pädiatrie I Department für Kinder- und Jugendheilkunde
Principal Investigator Name: Roman Crazzolara
Principal Investigator Email: Roman.crazzolara@i-med.ac.at
Contact Person Name: Roman Crazzolara
Contact Person Email: Roman.crazzolara@i-med.ac.at

Site Name: Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name: Kinderspital / Abteilung für Kinder- und Jugendheilkunde
Principal Investigator Name: Neil Jones
Principal Investigator Email: neil.jones@salk.at
Contact Person Name: Neil Jones
Contact Person Email: neil.jones@salk.at

Site Name: Johannes Kepler University Linz
Department Name: Med Campus IV
Principal Investigator Name: Georg Ebetsberger-Dachs
Principal Investigator Email: georg.ebetsberger-dachs@kepleruniklinikum.at
Contact Person Name: Georg Ebetsberger-Dachs
Contact Person Email: georg.ebetsberger-dachs@kepleruniklinikum.at

Site Name: Medical University Of Graz
Department Name: Klinische Abteilung für Pädiatrische Hämatologie/Onkologie
Principal Investigator Name: Martin Benesch
Principal Investigator Email: martin.benesch@medunigraz.at
Contact Person Name: Martin Benesch
Contact Person Email: martin.benesch@medunigraz.at

Belgium

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 21-01-2025
Processing Time Days: 82
Number Of Sites: 7
Number Of Participants: 16

Sites

Site Name: UZ Leuven
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Marleen Renard
Principal Investigator Email: marleen.renard@uzleuven.be
Contact Person Name: Marleen Renard
Contact Person Email: marleen.renard@uzleuven.be

Site Name: Centre Hospitalier Regional De La Citadelle
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Marie-Fracoise Dresse
Principal Investigator Email: mf.dresse@chuliege.be
Contact Person Name: Marie-Fracoise Dresse
Contact Person Email: mf.dresse@chuliege.be

Site Name: UZ Brussel
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Machiel Vanden Akker
Principal Investigator Email: machiel.vandenakker@uzbrussel.be
Contact Person Name: Machiel Vanden Akker
Contact Person Email: machiel.vandenakker@uzbrussel.be

Site Name: Antwerp University Hospital
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Jaques VanHeerden
Principal Investigator Email: Jaques.VanHeerden@uza.be
Contact Person Name: Jaques VanHeerden
Contact Person Email: Jaques.VanHeerden@uza.be

Site Name: Universitair Ziekenhuis Gent
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Bram De Wilde
Principal Investigator Email: bram.dewilde@uzgent.be
Contact Person Name: Bram De Wilde
Contact Person Email: bram.dewilde@uzgent.be

Site Name: Cliniques Universitaires Saint-Luc
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Benedicte Brichard
Principal Investigator Email: benedicte.brichard@saintluc.uclouvain.be
Contact Person Name: Benedicte Brichard
Contact Person Email: benedicte.brichard@saintluc.uclouvain.be

Site Name: UZ Leuven (duplicate listing in dataset)
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Marleen Renard
Principal Investigator Email: marleen.renard@uzleuven.be
Contact Person Name: Marleen Renard
Contact Person Email: marleen.renard@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 24-01-2025
Processing Time Days: 85
Number Of Sites: 2
Number Of Participants: 12

Sites

Site Name: Charles University Hospital
Department Name: Department of Pediatric Hematology and Oncology
Principal Investigator Name: Josef Mališ
Principal Investigator Email: Josef.Malis@fnmotol.cz
Contact Person Name: Josef Mališ
Contact Person Email: Josef.Malis@fnmotol.cz

Site Name: Fakultni Nemocnice Brno
Department Name: Department of Pediatric Oncology
Principal Investigator Name: Viera Bajčiová
Principal Investigator Email: Bajciova.Viera@fnbrno.cz
Contact Person Name: Viera Bajčiová
Contact Person Email: Bajciova.Viera@fnbrno.cz

France

Earliest CTIS Part Ii Submission Date: 18-11-2024
Latest Decision Or Authorization Date: 23-01-2025
Processing Time Days: 66
Number Of Sites: 29
Number Of Participants: 82

Sites

Site Name: Centre Hospitalier Universitaire De Dijon
Department Name: Onco-Hémato-Pédiatrie
Principal Investigator Name: Florent Neumann
Principal Investigator Email: florent.neumann@chu-dijon.fr
Contact Person Name: Florent Neumann
Contact Person Email: florent.neumann@chu-dijon.fr

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Cécile Verite
Principal Investigator Email: cecile.verite@chu-bordeaux.fr
Contact Person Name: Cécile Verite
Contact Person Email: cecile.verite@chu-bordeaux.fr

Site Name: Centre Hospitalier Universitaire D'Angers
Department Name: Unité Hémato-Immuno-Oncologie Pédiatrique
Principal Investigator Name: Stephanie Proust
Principal Investigator Email: stproust@chu-angers.fr
Contact Person Name: Stephanie Proust
Contact Person Email: stproust@chu-angers.fr

Site Name: Institut Gustave Roussy
Department Name: Cancérologie de l’Enfant et de l’Adolescent
Principal Investigator Name: Brice Fresneau
Principal Investigator Email: brice.fresneau@gustaveroussy.fr
Contact Person Name: Brice Fresneau
Contact Person Email: brice.fresneau@gustaveroussy.fr

Site Name: University Hospital Of Clermont-Ferrand
Department Name: Hématologie Oncologie Pédiadrique - SHOP
Principal Investigator Name: Justyna Kanold
Principal Investigator Email: jkanold@chu-clermontferrand.fr
Contact Person Name: Justyna Kanold
Contact Person Email: jkanold@chu-clermontferrand.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Hématologie et oncologie Pédiatrique
Principal Investigator Name: Marie-Dominique Tabone
Principal Investigator Email: marie-dominique.tabone@aphp.fr
Contact Person Name: Marie-Dominique Tabone
Contact Person Email: marie-dominique.tabone@aphp.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Joy Benadiba
Principal Investigator Email: benadiba.j@chu-nice.fr
Contact Person Name: Joy Benadiba
Contact Person Email: benadiba.j@chu-nice.fr

Site Name: Centre Hospitalier Universitaire De Nantes
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Estelle Thebaud
Principal Investigator Email: estelle.thebaud@chu-nantes.fr
Contact Person Name: Estelle Thebaud
Contact Person Email: estelle.thebaud@chu-nantes.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Hématologie et oncologie pédiatrique
Principal Investigator Name: Claire Berger
Principal Investigator Email: claire.berger@chu-st-etienne.fr
Contact Person Name: Claire Berger
Contact Person Email: claire.berger@chu-st-etienne.fr

Site Name: Centre Hospitalier Regional Universitaire De Tours
Department Name: Oncologie - Hématologie Pédiatrique
Principal Investigator Name: Pascale Blouin
Principal Investigator Email: p.blouin@chu-tours.fr
Contact Person Name: Pascale Blouin
Contact Person Email: p.blouin@chu-tours.fr

Site Name: Centre Oscar Lambret
Department Name: Unité d'Oncologie Pédiatrique
Principal Investigator Name: Hélène Sudour
Principal Investigator Email: h-sudour@o-lambret.fr
Contact Person Name: Hélène Sudour
Contact Person Email: h-sudour@o-lambret.fr

Site Name: Les Hopitaux Universitaires De Strasbourg
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Catherine Paillard
Principal Investigator Email: catherine.paillard@chru-strasbourg.fr
Contact Person Name: Catherine Paillard
Contact Person Email: catherine.paillard@chru-strasbourg.fr

Site Name: Centre Hospitalier Universitaire Reims
Department Name: Hématologie-oncologie Pédiatrique
Principal Investigator Name: Claire Pluchart
Principal Investigator Email: cpluchart@chu-reims.fr
Contact Person Name: Claire Pluchart
Contact Person Email: cpluchart@chu-reims.fr

Site Name: Centre Hospitalier Universitaire Rouen
Department Name: Immuno Hémato Onco Pédiatrie
Principal Investigator Name: Cécile Dumesnil
Principal Investigator Email: cecile.dumesnil@chu-rouen.fr
Contact Person Name: Cécile Dumesnil
Contact Person Email: cecile.dumesnil@chu-rouen.fr

Site Name: Centre Hospitalier Et Universitaire De Limoges
Department Name: Hématologie-oncologie Pédiatrique
Principal Investigator Name: Christophe Piguet
Principal Investigator Email: christophe.piguet@chu-limoges.fr
Contact Person Name: Christophe Piguet
Contact Person Email: christophe.piguet@chu-limoges.fr

Site Name: Centre Hospitalier Universitaire Grenoble Alpes
Department Name: Immuno-Hémato-Oncologie Pédiatrique
Principal Investigator Name: Gaëlle Stofleth
Principal Investigator Email: gstofleth@chu-grenoble.fr
Contact Person Name: Gaëlle Stofleth
Contact Person Email: gstofleth@chu-grenoble.fr

Site Name: Centre Hospitalier Regional De Marseille
Department Name: Hématologie-oncologie Pédiatrique
Principal Investigator Name: Carole Coze
Principal Investigator Email: carole.coze@ap-hm.fr
Contact Person Name: Carole Coze
Contact Person Email: carole.coze@ap-hm.fr

Site Name: CHU Besancon
Department Name: Hématologie Oncologie Pédiatrique
Principal Investigator Name: Véronique Laithier
Principal Investigator Email: vlaithier@chu-besancon.fr
Contact Person Name: Véronique Laithier
Contact Person Email: vlaithier@chu-besancon.fr

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Marianna Deparis
Principal Investigator Email: deparis-m@chu-caen.fr
Contact Person Name: Marianna Deparis
Contact Person Email: deparis-m@chu-caen.fr

Site Name: Centre Hospitalier Universitaire De La Reunion
Department Name: Oncologie et Hématologie Pédiatrique
Principal Investigator Name: Yves Reguerre
Principal Investigator Email: yves.reguerre@chu-reunion.fr
Contact Person Name: Yves Reguerre
Contact Person Email: yves.reguerre@chu-reunion.fr

Site Name: CHRU De Nancy
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Ludovic Mansuy
Principal Investigator Email: lu.mansuy@chru-nancy.fr
Contact Person Name: Ludovic Mansuy
Contact Person Email: lu.mansuy@chru-nancy.fr

Site Name: Institut Curie
Department Name: Pédiatrique
Principal Investigator Name: Isabelle Aerts
Principal Investigator Email: isabelle.aerts@curie.fr
Contact Person Name: Isabelle Aerts
Contact Person Email: isabelle.aerts@curie.fr

Site Name: Centre Hospitalier Universitaire De Rennes
Department Name: Hématologie-oncologie Pédiatrique
Principal Investigator Name: Sophie Taque
Principal Investigator Email: sophie.taque@chu-rennes.fr
Contact Person Name: Sophie Taque
Contact Person Email: sophie.taque@chu-rennes.fr

Site Name: Centre Leon Berard
Department Name: Oncologie Pédiatrique
Principal Investigator Name: Cécile Faure Conter
Principal Investigator Email: cecile.conter@ihope.fr
Contact Person Name: Cécile Faure Conter
Contact Person Email: cecile.conter@ihope.fr

Site Name: Centre Hospitalier Universitaire De Poitiers
Department Name: Onco-hématologie pédiatrique
Principal Investigator Name: Frédéric Millot
Principal Investigator Email: frederic.millot@chu-poitiers.fr
Contact Person Name: Frédéric Millot
Contact Person Email: frederic.millot@chu-poitiers.fr

Site Name: Centre Hospitalier Regional Et Universitaire De Brest
Department Name: Pédiatrie Spécialisée
Principal Investigator Name: Liana Carausu
Principal Investigator Email: liana.carausu@chu-brest.fr
Contact Person Name: Liana Carausu
Contact Person Email: liana.carausu@chu-brest.fr

Site Name: Centre Hospitalier Universitaire Amiens Picardie
Department Name: Onco-Hématologie Pédiatrique
Principal Investigator Name: Antoine Gourmel
Principal Investigator Email: Gourmel.Antoine@chu-amiens.fr
Contact Person Name: Antoine Gourmel
Contact Person Email: Gourmel.Antoine@chu-amiens.fr

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: Hémotologie et oncologie pédiatrique
Principal Investigator Name: Stéphanie Haouy
Principal Investigator Email: s-haouy@chu-montpellier.fr
Contact Person Name: Stéphanie Haouy
Contact Person Email: s-haouy@chu-montpellier.fr

Site Name: Centre Hospitalier Universitaire De Toulouse
Department Name: Oncologie - Hématologie Pédiatrique
Principal Investigator Name: Cécile Boulanger
Principal Investigator Email: boulanger.c@chu-toulouse.fr
Contact Person Name: Cécile Boulanger
Contact Person Email: boulanger.c@chu-toulouse.fr

Ireland

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 21-01-2025
Processing Time Days: 82
Number Of Sites: 1
Number Of Participants: 7

Sites

Site Name: Children's Health Ireland
Department Name: Oncolgy
Principal Investigator Name: Michael Capra
Principal Investigator Email: michael.capra@childrenshealthireland.ie
Contact Person Name: Michael Capra
Contact Person Email: michael.capra@childrenshealthireland.ie

Spain

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 22-01-2025
Processing Time Days: 83
Number Of Sites: 15
Number Of Participants: 57

Sites

Site Name: University Hospital Son Espases
Department Name: Pediatry
Principal Investigator Name: José Antonio Salinas Sanz
Principal Investigator Email: josea.salinas@ssib.es
Contact Person Name: José Antonio Salinas Sanz
Contact Person Email: josea.salinas@ssib.es

Site Name: Hospital Universitario Regional De Malaga
Department Name: Pediatric Oncology Unit
Principal Investigator Name: Guiomar Gutiérrez Schiaffino
Principal Investigator Email: guiogs@hotmail.com
Contact Person Name: Guiomar Gutiérrez Schiaffino
Contact Person Email: guiogs@hotmail.com

Site Name: Hospital General Universitario Gregorio Maranon
Department Name: Pediatry
Principal Investigator Name: Jorge Huerta Aragonés
Principal Investigator Email: jhuertapediatria@yahoo.es
Contact Person Name: Jorge Huerta Aragonés
Contact Person Email: jhuertapediatria@yahoo.es

Site Name: Hospital Universitario Miguel Servet
Department Name: Pediatry
Principal Investigator Name: Ascensión Muñoz Mellado
Principal Investigator Email: amunnozmel@salud.aragon.es
Contact Person Name: Ascensión Muñoz Mellado
Contact Person Email: amunnozmel@salud.aragon.es

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Pediatric Oncology Unit
Principal Investigator Name: Mercedes Livia Llempén López
Principal Investigator Email: mlivia39@gmail.com
Contact Person Name: Mercedes Livia Llempén López
Contact Person Email: mlivia39@gmail.com

Site Name: Hospital Universitari Vall D Hebron
Department Name: Pediatric Oncology, Haematology and bone Marrow Transplantation
Principal Investigator Name: Raquel Hladun Alvaro
Principal Investigator Email: raquel.hladun@vallhebron.cat
Contact Person Name: Raquel Hladun Alvaro
Contact Person Email: raquel.hladun@vallhebron.cat

Site Name: Hospital Universitario Hm Monteprincipe
Department Name: Pediatric Oncology and Hematology
Principal Investigator Name: Isabel Martínez Romera
Principal Investigator Email: imromera@hmhospitales.com
Contact Person Name: Isabel Martínez Romera
Contact Person Email: imromera@hmhospitales.com

Site Name: University Clinical Hospital Virgen De La Arrixaca
Department Name: Pediatry
Principal Investigator Name: María Esther Linares Riestra
Principal Investigator Email: mariae.llinares@carm.es
Contact Person Name: María Esther Linares Riestra
Contact Person Email: mariae.llinares@carm.es

Site Name: Hospital Sant Joan De Deu Barcelona
Department Name: Pediatric Oncology
Principal Investigator Name: Alicia Castañeda Heredia
Principal Investigator Email: alicia.castanedah@sjd.es
Contact Person Name: Alicia Castañeda Heredia
Contact Person Email: alicia.castanedah@sjd.es

Site Name: Hospital Universitario Y Politecnico La Fe
Department Name: Pediatric Oncology
Principal Investigator Name: Antonio Juan Ribelles
Principal Investigator Email: juan_antrib@gva.es
Contact Person Name: Antonio Juan Ribelles
Contact Person Email: juan_antrib@gva.es

Site Name: Hospital Universitario 12 De Octubre
Department Name: Pediatry
Principal Investigator Name: Vanesa Pérez Alonso
Principal Investigator Email: vpereza@salud.madrid.org
Contact Person Name: Vanesa Pérez Alonso
Contact Person Email: vpereza@salud.madrid.org

Site Name: Hospital Universitario Reina Sofia
Department Name: Pediatry
Principal Investigator Name: María Elena Mateos González
Principal Investigator Email: mariae.mateos.sspa@juntadeandalucia.es
Contact Person Name: María Elena Mateos González
Contact Person Email: mariae.mateos.sspa@juntadeandalucia.es

Site Name: Hospital Universitario De Canarias
Department Name: Pediatric Oncology and Haematology Unit
Principal Investigator Name: Macarena González Cruz
Principal Investigator Email: magoncru@gobiernodecanarias.org
Contact Person Name: Macarena González Cruz
Contact Person Email: magoncru@gobiernodecanarias.org

Site Name: Hospital Universitario De Cruces
Department Name: Pediatric Oncology and Haematology
Principal Investigator Name: Ricardo López Almaraz
Principal Investigator Email: RICARDO.LOPEZALMARAZ@osakidetza.eus
Contact Person Name: Ricardo López Almaraz
Contact Person Email: RICARDO.LOPEZALMARAZ@osakidetza.eus

Site Name: Hospital Universitario La Paz
Department Name: Pediatric Haemato-Oncology
Principal Investigator Name: Diego Plaza López de
Principal Investigator Email: Diego.plaza@saludmadrid.org
Contact Person Name: Diego Plaza López de
Contact Person Email: Diego.plaza@saludmadrid.org

Netherlands

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 23-01-2025
Processing Time Days: 84
Number Of Sites: 1
Number Of Participants: 21

Sites

Site Name: Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name: Solid Tumours
Principal Investigator Name: József Zsiros
Principal Investigator Email: J.Zsiros@prinsesmaximacentrum.nl
Contact Person Name: József Zsiros
Contact Person Email: J.Zsiros@prinsesmaximacentrum.nl

Poland

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 27-01-2025
Processing Time Days: 88
Number Of Sites: 10
Number Of Participants: 34

Sites

Site Name: Instytut Pomnik Centrum Zdrowia Dziecka
Department Name: Instytut Pomnik Centrum Zdrowia Dziecka, Klinika Onkologii
Principal Investigator Name: Ewa Swieszkowska
Principal Investigator Email: e.swieszkowska@ipczd.pl
Contact Person Name: Ewa Swieszkowska
Contact Person Email: e.swieszkowska@ipczd.pl

Site Name: Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name: Górnośląskie Centrum Zdrowia Dziecka im. Św. Jana Pawła II Samodzielny Publiczny Szpital Kliniczny
Principal Investigator Name: Agnieszka Mizia-Malarz
Principal Investigator Email: a.mizia@wp.pl
Contact Person Name: Agnieszka Mizia-Malarz
Contact Person Email: a.mizia@wp.pl

Site Name: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name: Katedra i Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej
Principal Investigator Name: Grazyna Wrobel
Principal Investigator Email: Wrobel.wroc@wp.pl
Contact Person Name: Grazyna Wrobel
Contact Person Email: Wrobel.wroc@wp.pl

Site Name: Uniwersyteckie Centrum Kliniczne
Department Name: Klinika Pediatrii Hematologii Onkologii, Gdanski Uniwersytet Medyczny
Principal Investigator Name: Joanna Stefanowicz
Principal Investigator Email: joanna.stefanowicz@gumed.edu.pl
Contact Person Name: Joanna Stefanowicz
Contact Person Email: joanna.stefanowicz@gumed.edu.pl

Site Name: Medical University Of Gdansk
Department Name: Oncology
Principal Investigator Name: Piortr Czauderna
Principal Investigator Email: pczaud@gumed.edu.pl
Contact Person Name: Piortr Czauderna
Contact Person Email: pczaud@gumed.edu.pl

Site Name: Uniwersytecki Szpital Dzieciecy W Krakowie
Department Name: Klinka Onkologii i Hematologii Dziecięcej, Instytut Pediatrii Wydział Lekarski Uniwersytetu Jagiello
Principal Investigator Name: Katarzyna Pawinska-Wasikowska
Principal Investigator Email: kpawinska@usdk.pl
Contact Person Name: Katarzyna Pawinska-Wasikowska
Contact Person Email: kpawinska@usdk.pl

Site Name: Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name: Samodzielny Publiczny Szpital Kliniczny
Principal Investigator Name: Tomasz Szczepanski
Principal Investigator Email: tszczepanski@sum.edu.pl
Contact Person Name: Tomasz Szczepanski
Contact Person Email: tszczepanski@sum.edu.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Department Name: Klinika Pediatrii, Onkologii i Immunologii Dzieciecej, Pomorski Uniwersytet Medyczny w Szczecinie
Principal Investigator Name: Pawel Wawrykow
Principal Investigator Email: Pawel.wawrykow@gmail.com
Contact Person Name: Pawel Wawrykow
Contact Person Email: Pawel.wawrykow@gmail.com

Site Name: Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Department Name: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhifa, Klinika Pediatri, Onkologii i Hematologi
Principal Investigator Name: Malgorzata Sawicka-Krawczuk-Rybak
Principal Investigator Email: mzukowska@interia.pl
Contact Person Name: Malgorzata Sawicka-Krawczuk-Rybak
Contact Person Email: mzukowska@interia.pl

Site Name: Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Department Name: Klinika Onkologii, Hematologii i Transplantologii Pediatrycznej Szpital Kliniczny im. Karola Jonsche
Principal Investigator Name: Patrycja Marciniak-Stepak
Principal Investigator Email: pmarciniak@ump.edu.pl
Contact Person Name: Patrycja Marciniak-Stepak
Contact Person Email: pmarciniak@ump.edu.pl

Germany

Earliest CTIS Part Ii Submission Date: 31-10-2024
Latest Decision Or Authorization Date: 23-01-2025
Processing Time Days: 84
Number Of Sites: 17
Number Of Participants: 42

Sites

Site Name: Universitaetsklinikum Essen AöR
Department Name: Klinik für Kinderheilkunde III
Principal Investigator Name: Michael Schündeln
Principal Investigator Email: Paedonko-studien@uk-essen.de
Contact Person Name: Michael Schündeln
Contact Person Email: Paedonko-studien@uk-essen.de

Site Name: Medizinische Hochschule Hannover
Department Name: Päd. Onkologie und Hämatologie
Principal Investigator Name: Andreas Beilken
Principal Investigator Email: Beilken.andreas@mh-hannover.de
Contact Person Name: Andreas Beilken
Contact Person Email: Beilken.andreas@mh-hannover.de

Site Name: Universitaetsklinikum Wuerzburg AöR
Department Name: Zentrum für Kinder
Principal Investigator Name: Paul Gerhardt Schlegel
Principal Investigator Email: Schlegel_P@ukw.de
Contact Person Name: Paul Gerhardt Schlegel
Contact Person Email: Schlegel_P@ukw.de

Site Name: Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name: Zentrum für Kinder- und Jugendmedizin
Principal Investigator Name: Claudia Blattmann
Principal Investigator Email: c.blattmann@klinikum-stuttgart.de
Contact Person Name: Claudia Blattmann
Contact Person Email: c.blattmann@klinikum-stuttgart.de

Site Name: Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Department Name: Klinik und Poliklinik für Kinder- und Jugendmedizin Pädiatrische Hämatologie/Onkologie/Hämostaseolog
Principal Investigator Name: Jörg Faber
Principal Investigator Email: kinderklinik@unimedizin-mainz.de
Contact Person Name: Jörg Faber
Contact Person Email: kinderklinik@unimedizin-mainz.de

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Abt. Kinderheilkunde I
Principal Investigator Name: Martin Ebinger
Principal Investigator Email: Martin.ebinger@med.uni-tuebingen.de
Contact Person Name: Martin Ebinger
Contact Person Email: Martin.ebinger@med.uni-tuebingen.de

Site Name: Klinikum Dortmund gGmbH
Department Name: Klinik für Kinder- und Jugendmedizin Kinderhämatologie und -onkologie
Principal Investigator Name: Dominik Schneider
Principal Investigator Email: Kinderklinik@klinikumdo.de
Contact Person Name: Dominik Schneider
Contact Person Email: Kinderklinik@klinikumdo.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Otto-Heubner-Centrum für Kinder- und Jugendmedizin Klinik für Pädiatrie m.S. Onkologie
Principal Investigator Name: Theresa Thole Kliesch
Principal Investigator Email: Theresa.thole@charite.de
Contact Person Name: Theresa Thole Kliesch
Contact Person Email: Theresa.thole@charite.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Klinik für Kinder- und Jugendmedizin 1, Sektion für Kinderonkologie und -hämatologie
Principal Investigator Name: Alexander Claviez
Principal Investigator Email: Alexander.claviez@med.ovgu.de
Contact Person Name: Alexander Claviez
Contact Person Email: Alexander.claviez@med.ovgu.de

Site Name: Universitaetsklinikum Leipzig AöR
Department Name: Kinder- und Jugendmedizin Kinder-Hämatologie und -Onkologie
Principal Investigator Name: Lars Fischer
Principal Investigator Email: lars.fischer@medizin.uni-leipzig.de
Contact Person Name: Lars Fischer
Contact Person Email: lars.fischer@medizin.uni-leipzig.de

Site Name: Goethe University Frankfurt
Department Name: Zentrum für Kinder- und Jugendmedizin
Principal Investigator Name: Konrad Bocheennek
Principal Investigator Email: konrad.bochennek@ukffm.de
Contact Person Name: Konrad Bocheennek
Contact Person Email: konrad.bochennek@ukffm.de

Site Name: Medical Center - University Of Freiburg
Department Name: Zentrum für Kinderheilkunde und Jugendmedizin
Principal Investigator Name: Simone Hettmer
Principal Investigator Email: Simone.hettmer@uniklinik-freiburg.de
Contact Person Name: Simone Hettmer
Contact Person Email: Simone.hettmer@uniklinik-freiburg.de

Site Name: Universitaetsklinikum des Saarlandes AöR
Department Name: Klinik für Pädiatrische Hämatologie / Onkologie
Principal Investigator Name: Norbert Graf
Principal Investigator Email: Norbert.graf@uks.eu
Contact Person Name: Norbert Graf
Contact Person Email: Norbert.graf@uks.eu

Site Name: Universitaetsklinikum Bonn AöR
Department Name: Zentrum für Kinderheilkunde Abt. Päd. Hämatologie/Onkologie
Principal Investigator Name: Gabriele Calaminus
Principal Investigator Email: Gabriele.calaminus@ukbonn.de
Contact Person Name: Gabriele Calaminus
Contact Person Email: Gabriele.calaminus@ukbonn.de

Site Name: Universitaetsklinikum Augsburg
Department Name: Kinderklinik
Principal Investigator Name: Michael Frühwald
Principal Investigator Email: Michael.fruehwald@klinikum-augsburg.de
Contact Person Name: Michael Frühwald
Contact Person Email: Michael.fruehwald@klinikum-augsburg.de

Site Name: Ludwig-Maximilians-Universitaet Muenchen
Department Name: Department of Paediatric Hematology and Oncology
Principal Investigator Name: Irene Schmid
Principal Investigator Email: Irene.schmid@med.uni-muenchen.de
Contact Person Name: Irene Schmid
Contact Person Email: Irene.schmid@med.uni-muenchen.de

Site Name: University Hospital Cologne AöR
Department Name: Zentrum für Kinderonkologie und – hämatologie
Principal Investigator Name: Thorsten Simon
Principal Investigator Email: thorsten.simon@uk-koeln.de
Contact Person Name: Thorsten Simon
Contact Person Email: thorsten.simon@uk-koeln.de

Norway

Earliest CTIS Part Ii Submission Date: 14-11-2024
Latest Decision Or Authorization Date: 21-01-2025
Processing Time Days: 68
Number Of Sites: 4
Number Of Participants: 10

Sites

Site Name: Universitetssykehuset Nord-Norge HF
Department Name: Dep.of pediatric hematology and oncology
Principal Investigator Name: Tove Nystad
Principal Investigator Email: Tove.Anita.Nystad@unn.no
Contact Person Name: Tove Nystad
Contact Person Email: Tove.Anita.Nystad@unn.no

Site Name: Helse Bergen HF
Department Name: Dep.of pediatric hematology and oncology
Principal Investigator Name: Dorota Wojcik
Principal Investigator Email: dorota.malgorzata.wojcik@helse-bergen.no
Contact Person Name: Dorota Wojcik
Contact Person Email: dorota.malgorzata.wojcik@helse-bergen.no

Site Name: Oslo University Hospital HF
Department Name: Dep.of pediatric hematology and oncology
Principal Investigator Name: Marta Mari Burman
Principal Investigator Email: mardir@ous-hf.no
Contact Person Name: Marta Mari Burman
Contact Person Email: mardir@ous-hf.no

Site Name: St. Olavs Hospital HF
Department Name: Dep.of pediatric hematology and oncology
Principal Investigator Name: Erling Moe
Principal Investigator Email: Erling.Johan.Moe@stolav.no
Contact Person Name: Erling Moe
Contact Person Email: Erling.Johan.Moe@stolav.no

Sponsor

Primary sponsor

Full Name: The University Of Birmingham
Organisation Type: Educational Institution
Country Of Registered Address: United Kingdom

Investigational products

Investigational Product Name: CISPLATIN
Active Substance: CISPLATIN
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 600

Investigational Product Name: CARBOPLATIN
Active Substance: CARBOPLATIN
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 3900

Investigational Product Name: DOXORUBICIN HYDROCHLORIDE
Active Substance: DOXORUBICIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 300

Investigational Product Name: FLUOROURACIL
Active Substance: FLUOROURACIL
Modality: Small molecule
Routes Of Administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status: 2
Maximum Dose: 3600

Investigational Product Name: ETOPOSIDE
Active Substance: ETOPOSIDE
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 1200

Investigational Product Name: SORAFENIB
Active Substance: SORAFENIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: 2
Maximum Dose: 32400

Investigational Product Name: IRINOTECAN
Active Substance: IRINOTECAN
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 300

Investigational Product Name: OXALIPLATIN
Active Substance: OXALIPLATIN
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 400

Investigational Product Name: VINCRISTINE SULFATE
Active Substance: VINCRISTINE SULFATE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status: 2
Maximum Dose: 12

Investigational Product Name: GEMCITABINE HYDROCHLORIDE
Active Substance: GEMCITABINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: 2
Maximum Dose: 4000

Combination Treatment: Yes

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