Clinical trial • Phase IV • Oncology|Ophthalmology
VINCRISTINE SULFATE for Retinoblastoma
Phase IV trial of VINCRISTINE SULFATE for Retinoblastoma. 195 participants.
Overview
- Trial Therapeutic Area
- Oncology|Ophthalmology
- Trial Disease
- Retinoblastoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 14-08-2024
Trial design
Phase IV trial across 27 sites in France.
- Target Sample Size
- 195
Eligibility
Recruits 195 paediatric patients.
- Vulnerable Population
- Participants are children (aged ≥2 months and <10 years). Written informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines; consent may be provided by parents or legal representatives as appropriate.
Inclusion criteria
- {"criterion_text":"- Male or female ≥2 months and <10 years of age at the time of signing the informed consent form;\n- Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation\n- No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor type.\n- Without medical cons-indication to study drugs.\n- Long term follow –up possible.\n- Written informed consent – a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines\n- Patients affiliated to a Social Security Regimen or beneficiary of the same\n- In case of post operative chemotherapy, patients must have adequate organ function: a- Adequate hematopoietic function Neutrophils>1.0x109/l, Platelets >100 x 109/l. b- Adequate hepatic function: grade II NCI CTC. c- Adequate renal function: serum creatinemia <1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula. d- Audiometry < Grade II de Brock. e-\tEchocardiography normal in case of high dose cyclophophamide chemotherapy (3 g/m²)."}
Exclusion criteria
- {"criterion_text":"- Bilateral and/or familial or trilateral retinoblastoma.\n- Unilateral retinoblastoma with indication of primary chemotherapy before enucleation: 1- One or several surgical risk factors : - Buphtalmia Exophtalmia. - Peri ocular inflamatory signs. 2- Extraocular extension : - Radiological retrolaminar extension (more than 3 mm behind the lamina cribosa) and or meningeal sheat optic nerve extension. - Extrascleral extension. - Lymp nodes extension.\n- Unilateral retinoblastoma with possibility of conservative treatment: - lesion(s) taking up less than 2/3 of the eyeball. - preservation of macula and papilla.\n- Metastatic extension at diagnosis\n- One inclusion criteria non observed.\n- Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Rate of extra ocular relapses","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patient with secondary bilateralisation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Evaluate the different histopathological risk factors frequency.","definition_or_measurement_approach":""}
- {"endpoint_text":"- To determine tumors genomic.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Evaluate sensitivity of MRI in detecting extra ocular extension.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 195
- Recruitment Window Months
- 246
- Consent Approach
- Written informed consent – a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines. Consent may be provided by parents or legal representatives; assent obtained where age-appropriate.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 195
France
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 01-07-2025
- Processing Time Days
- 365
- Number Of Sites
- 27
- Number Of Participants
- 195
Sites
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Claire BRIANDET
- Principal Investigator Email
- claire.briandet@chu-dijon.fr
- Contact Person Name
- Claire BRIANDET
- Contact Person Email
- claire.briandet@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Unité d’Hématologie/Oncologie/Immunologie Pédiatrique
- Principal Investigator Name
- Isabelle PELLIER
- Principal Investigator Email
- IsPellier@chu-angers.fr
- Contact Person Name
- Isabelle PELLIER
- Contact Person Email
- IsPellier@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Hémato-Oncologie Pédiatrique
- Principal Investigator Name
- Claire PLUCHARD
- Principal Investigator Email
- cpluchart@chu-reims.fr
- Contact Person Name
- Claire PLUCHARD
- Contact Person Email
- cpluchart@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hémato-oncologie Pédiatrique
- Principal Investigator Name
- Anne-Isabelle BERTOZZI-SALAMON
- Principal Investigator Email
- bertozzi.ai@chu-toulouse.fr
- Contact Person Name
- Anne-Isabelle BERTOZZI-SALAMON
- Contact Person Email
- bertozzi.ai@chu-toulouse.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Onco-Hématologie 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
- CHU Besancon
- Department Name
- pediatrie oncologie hematologie
- 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 Regional Et Universitaire De Brest
- Department Name
- Onco-Hématologie pédiatrique
- Principal Investigator Name
- Liana CARAUSU
- Principal Investigator Email
- liana.carasu@chu-brest.fr
- Contact Person Name
- Liana CARAUSU
- Contact Person Email
- liana.carasu@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Onco-Hématologie Pédiatrique
- Principal Investigator Name
- Marilyne DUPUY-POIREE
- Principal Investigator Email
- poiree.m@chu-nice.fr
- Contact Person Name
- Marilyne DUPUY-POIREE
- Contact Person Email
- poiree.m@chu-nice.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Natacha ENTZ WERLE
- Principal Investigator Email
- Natacha.Entz-Werle@chru-strasbourg.fr
- Contact Person Name
- Natacha ENTZ WERLE
- Contact Person Email
- Natacha.Entz-Werle@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Onco-Hématologie pédiatrique
- Principal Investigator Name
- Damien BODET
- Principal Investigator Email
- bodet-d@chu-caen.fr
- Contact Person Name
- Damien BODET
- Contact Person Email
- bodet-d@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hématologie et Oncologie Pédiatriques
- Principal Investigator Name
- Nicolas SIRVENT
- Principal Investigator Email
- n-sirvent@chu-montpellier.fr
- Contact Person Name
- Nicolas SIRVENT
- Contact Person Email
- n-sirvent@chu-montpellier.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
- Institut Curie
- Department Name
- Pédiatrie
- 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 Rouen
- Department Name
- Hémato-Immuno-Oncologie Pédiatrique
- Principal Investigator Name
- Pascale SCHNEIDER
- Principal Investigator Email
- pascale.schneider@chu-rouen.fr
- Contact Person Name
- Pascale SCHNEIDER
- Contact Person Email
- pascale.schneider@chu-rouen.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Onco hématologie 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
- Centre Leon Berard
- Department Name
- Pédiatrie
- Principal Investigator Name
- Benoit DUMONT
- Principal Investigator Email
- benoit.dumont@ihope.fr
- Contact Person Name
- Benoit DUMONT
- Contact Person Email
- benoit.dumont@ihope.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Onco-Hématologie pédiatrique
- Principal Investigator Name
- Camille KHANFAR
- Principal Investigator Email
- khanfar.camille@chu-amiens.fr
- Contact Person Name
- Camille KHANFAR
- Contact Person Email
- khanfar.camille@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hématologie Onco-Pédiatrique
- Principal Investigator Name
- Frédéric MILLOT
- Principal Investigator Email
- f.millot@chu-poitiers.fr
- Contact Person Name
- Frédéric MILLOT
- Contact Person Email
- f.millot@chu-poitiers.fr
- Site Name
- CHRU De Nancy
- Department Name
- Onco hématologie pédiatrique
- Principal Investigator Name
- Ludovic MANSUY
- Principal Investigator Email
- ludovic.mansuy@chu-nancy.fr
- Contact Person Name
- Ludovic MANSUY
- Contact Person Email
- ludovic.mansuy@chu-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pédiatrie
- Principal Investigator Name
- Céline de BOUYN-ICHER
- Principal Investigator Email
- celine.icher@chu-bordeaux.fr
- Contact Person Name
- Céline de BOUYN-ICHER
- Contact Person Email
- celine.icher@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- héHématologie et oncologie pédiatrique
- Principal Investigator Name
- Jean-Louis STEPHAN
- Principal Investigator Email
- j.louis.stephan@chu-st-etienne.fr
- Contact Person Name
- Jean-Louis STEPHAN
- Contact Person Email
- j.louis.stephan@chu-st-etienne.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Onco-hématologie pédiatrique
- 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
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service Hématologie Pédiatrique
- Principal Investigator Name
- Chloé PUISEUX
- Principal Investigator Email
- chloe.puiseux@chu-rennes.fr
- Contact Person Name
- Chloé PUISEUX
- Contact Person Email
- chloe.puiseux@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hémato-Oncologie Infantile
- 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 Grenoble Alpes
- Department Name
- Immuno-onco-hemato-pediatrie
- Principal Investigator Name
- Anne PAGNIER
- Principal Investigator Email
- APagnier@chu-grenoble.fr
- Contact Person Name
- Anne PAGNIER
- Contact Person Email
- APagnier@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De La Reunion
- Department Name
- Oncologie 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
- Centre Oscar Lambret
- Department Name
- Unité de Pédiatrie
- 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
Sponsor
Primary sponsor
- Full Name
- Institut Curie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- ONCOVIN 1 mg, solution injectable
- Active Substance
- VINCRISTINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Authorised
- Investigational Product Name
- CARBOPLATINE TEVA 10 mg/ml, solution pour perfusion
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised
- Investigational Product Name
- ENDOXAN 1000 mg, poudre pour solution injectable
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised
- Investigational Product Name
- ETOPOSIDE TEVA 20 mg/ml, solution à diluer pour perfusion
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised
- Investigational Product Name
- TEPADINA 15 mg powder for concentrate for solution for infusion
- Active Substance
- THIOTEPA
- Modality
- Small molecule
- Routes Of Administration
- INTRATHECAL USE / SOLUTION FOR INFUSION
- Route
- INTRATHECAL USE
- Authorisation Status
- Authorised
- Investigational Product Name
- THIOTEPA GENOPHARM 15 mg, lyophilisat pour usage parentéral
- Active Substance
- THIOTEPA
- Modality
- Small molecule
- Routes Of Administration
- INTRATHECAL USE / SOLUTION FOR INJECTION/INFUSION
- Route
- INTRATHECAL USE
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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