Clinical trial • Phase III • Oncology

OXALIPLATIN for Metastatic colorectal cancer (liver metastases)

Phase III trial of OXALIPLATIN for Metastatic colorectal cancer (liver metastases).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic colorectal cancer (liver metastases)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
08-11-2024

Trial design

Randomised, intra-arterial oxaliplatin (eloxatine 5 mg/ml) 85 mg/m2 versus intravenous oxaliplatin (eloxatine 5 mg/ml) 85 mg/m2; both given in combination with lv5fu2 ± irinotecan and targeted therapy. exact schedule not specified.-controlled Phase III trial across 48 sites in Belgium, France.

Randomised
Yes
Comparator
Intra-arterial oxaliplatin (ELOXATINE 5 mg/ml) 85 mg/m2 versus intravenous oxaliplatin (ELOXATINE 5 mg/ml) 85 mg/m2; both given in combination with LV5FU2 ± Irinotecan and targeted therapy. Exact schedule not specified.
Target Sample Size
348

Eligibility

Recruits 348 The trial excludes persons deprived of liberty or under supervision. Informed consent is required from participants (see inclusion: 'Patient information and signature of the informed consent'); subject information and informed consent forms are provided (documents include L1_SIS and ICF V2 2021 FR and NL). Participants are adults (Age ≥ 18)..

Pregnancy Exclusion
Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
Vulnerable Population
The trial excludes persons deprived of liberty or under supervision. Informed consent is required from participants (see inclusion: 'Patient information and signature of the informed consent'); subject information and informed consent forms are provided (documents include L1_SIS and ICF V2 2021 FR and NL). Participants are adults (Age ≥ 18).

Inclusion criteria

  • {"criterion_text":"- Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)"}
  • {"criterion_text":"- At least one measurable hepatic metastasis according to the criteria RECIST v1.1"}
  • {"criterion_text":"- No other metastatic sites except lung nodules accepted if number ≤ 3 and < 10 mm"}
  • {"criterion_text":"- RAS mutation status known (determination of KRAS mutation [exons 2,3 and 4]and NRAS [exons 2,3 and 4])"}
  • {"criterion_text":"- Age ≥ 18"}
  • {"criterion_text":"- OMS ≤ 2"}
  • {"criterion_text":"- No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months and the 1st course of FOLFOX or mFOLFIRINOX IV without targeted therapy before randomisation (protocolar treatment)"}
  • {"criterion_text":"- Life expectancy > 3 months"}
  • {"criterion_text":"- PNN > 1500 /mm3, platelets > 100 000/mm3, Hb > 9 g/dL"}
  • {"criterion_text":"- Total bilirubin < 25 μmol/L, AST < 5x UNL, ALT < 5 x UNL, x UNL, ALP < 5 x UNL, PT > 60%, proteinuria from 24H < 1 g"}
  • {"criterion_text":"- Creatinine clearance > 50 mL/min according to MDRD formula"}
  • {"criterion_text":"- Patient affiliated to a social security scheme"}
  • {"criterion_text":"- Patient information and signature of the informed consent"}

Exclusion criteria

  • {"criterion_text":"- Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection."}
  • {"criterion_text":"- Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR"}
  • {"criterion_text":"- Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack"}
  • {"criterion_text":"- Hypertension not controlled by medical treatment (SBP> 140 mmHg and/or DBP> 90 mmHg with blood pressure taken according to the diagram of the HAS)"}
  • {"criterion_text":"- A history of abdominal fistula, gastrointestinal perforation, intraabdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment"}
  • {"criterion_text":"- Progressive gastroduodenal ulcer, wound or fractured bone"}
  • {"criterion_text":"- Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment"}
  • {"criterion_text":"- Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment - Transplant patients, HIV positive or other immune deficiency syndromes"}
  • {"criterion_text":"- Transplant patients, HIV positive or other immune deficiency syndromes"}
  • {"criterion_text":"- Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure"}
  • {"criterion_text":"- Peripheral neuropathy > 1 (NCI CT v4.0)"}
  • {"criterion_text":"- Patient with interstitial pneumonitis or pulmonary fibrosis"}
  • {"criterion_text":"- History of chronic diarrhea or inflammatory disease of the intestine, colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment"}
  • {"criterion_text":"- History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated"}
  • {"criterion_text":"- Patient already included in another clinical trial with an experimental molecule"}
  • {"criterion_text":"- Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)"}
  • {"criterion_text":"- Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)"}
  • {"criterion_text":"- QT/QTc range > 450 msec for men and > 470 msec for women"}
  • {"criterion_text":"- K+ < LNL, Mg2+ < LNL, Ca2+ < LNL"}
  • {"criterion_text":"- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test"}
  • {"criterion_text":"- Persons deprived of liberty or under supervision"}
  • {"criterion_text":"- Information du patient et signature du consentement éclairé"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Comparison of radiological and/or clinical progression free survival between intra-arterial administration of oxaliplatin (arms A and C) and intravenous administration of oxaliplatin (arms B and D). Progression was assessed according to the criteria RECIST v1.1 and according to the investigator.","definition_or_measurement_approach":"Progression assessed according to RECIST v1.1 and according to the investigator (radiological and/or clinical progression-free survival)."}

Secondary endpoints

  • {"endpoint_text":"- The adverse events will be graded according to NCI CTCAE v4.0 before each chemotherapy cycle.","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v4.0 prior to each cycle."}
  • {"endpoint_text":"- The best response under treatment will be evaluated based on the response RECIST v1.1 according to the investigator to the different Xrays; it will be described by the levels in the different categories: complete or partial response, stability, progression or non-evaluable.","definition_or_measurement_approach":"Best response per RECIST v1.1 by investigator, categorized as complete response, partial response, stable disease, progression or non-evaluable."}
  • {"endpoint_text":"- Overall survival: defined by the time between the date of treatment beginning and the date of death, whatever the cause; patients alive will be censured at the date of latest news.","definition_or_measurement_approach":"Time from treatment start to death from any cause; censored at last known alive date."}
  • {"endpoint_text":"- Hepatic progression free survival: defined by the time between the date of treatment beginning and the date of first hepatic progression or death, whatever the cause; patients alive without progression will be censured at the date of latest news.","definition_or_measurement_approach":"Time from treatment start to first hepatic progression or death; censored at last news if alive without progression."}
  • {"endpoint_text":"- Early tumour shrinkage (difference > 20%) at 8 weeks: defined as the relative difference between the sum of the largest diameters of the RECIST target lesions at 8 weeks and this sum at inclusion (prior to C1 before randomization).","definition_or_measurement_approach":"Relative difference between sum of largest diameters of RECIST target lesions at 8 weeks versus baseline; >20% considered early tumour shrinkage."}
  • {"endpoint_text":"- Depth of response: defined as the relative difference between the sum of the largest diameters of the RECIST target lesions in the NADIR (in the absence of new lesions or progression of non-target lesions) and the sum of the largest diameters of the RECIST target lesions at inclusion.","definition_or_measurement_approach":"Relative difference between nadir sum of RECIST target lesion diameters (absent new lesions/progression) and baseline sum."}
  • {"endpoint_text":"- Secondary resection rate: Rate of patients who were able to benefit from a resection of their tumor (primary and/or secondary) after treatment (by mentioning the character R0, R1 or R2)","definition_or_measurement_approach":"Proportion of patients undergoing secondary surgical resection after treatment; resection classified as R0/R1/R2."}
  • {"endpoint_text":"- Evaluation of the histological response, TRG (Rubbia-Brandt L et al. Annals Oncol 2007) in case of hepatic resection","definition_or_measurement_approach":"Histological response assessed using TRG (Rubbia-Brandt) for patients undergoing hepatic resection."}
  • {"endpoint_text":"- Evolution of the marker during treatment","definition_or_measurement_approach":"Change over time of tumoral marker (e.g., CEA) during treatment."}
  • {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Quality of life measured (QLQ-C30 specified in secondary objectives)."}
  • {"endpoint_text":"- Progression free survival under 'active' treatment defined by the time between the date of treatment beginning and the date of first progression under treatment (excluding therapeutic break) or death, whatever the cause; patients alive without progression will be censured at the date of latest news.","definition_or_measurement_approach":"Time from treatment start to first progression occurring while on active treatment (excluding treatment breaks) or death; censored at last news if alive without progression."}

Recruitment

Planned Sample Size
348
Recruitment Window Months
110
Consent Approach
Informed consent is required from participants (inclusion: 'Patient information and signature of the informed consent'). Subject information and informed consent forms are available in French and Dutch (documents: 'L1_SIS and ICF V2 2021 FR', 'L1_ SIS ans ICF V2 2021 NL'). Only adults (Age ≥ 18) are eligible, so no assent procedures for minors are described.

Geography

Total Number Of Sites
48
Total Number Of Participants
348

Belgium

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
08-11-2024
Processing Time Days
2
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
HUB Hôpital Erasme
Department Name
gastroenterology department
Principal Investigator Name
Gontran verset
Principal Investigator Email
gontran.verset@erasme.ulb.ac.be
Contact Person Name
Gontran verset

France

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
405
Number Of Sites
47
Number Of Participants
338

Sites

Site Name
Hospital Hotel Dieu
Department Name
Hepato-gastroenterology
Principal Investigator Name
Yann TOUCHEFEU
Principal Investigator Email
yann.touchefeu@chu-nantes.fr
Contact Person Name
Yann TOUCHEFEU
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Hepato-gastroenterology
Principal Investigator Name
Margot LALY
Principal Investigator Email
margot.laly@ght85.fr
Contact Person Name
Margot LALY
Contact Person Email
margot.laly@ght85.fr
Site Name
Hopital Prive D Antony
Department Name
Oncology
Principal Investigator Name
Anne THIROT-BIDAULT
Principal Investigator Email
a.t.bidault@gmail.com
Contact Person Name
Anne THIROT-BIDAULT
Contact Person Email
a.t.bidault@gmail.com
Site Name
Centre Hospitalier Simone Veil De Beauvais
Department Name
Medical Oncology
Principal Investigator Name
Hanifa AMMARGUELLAT
Principal Investigator Email
h.ammarguellat@ch-beauvais.fr
Contact Person Name
Hanifa AMMARGUELLAT
Contact Person Email
h.ammarguellat@ch-beauvais.fr
Site Name
Hôpital Cochin
Department Name
gastro enterology
Principal Investigator Name
Romain CORIAT
Principal Investigator Email
romain.coriat@aphp.fr
Contact Person Name
Romain CORIAT
Contact Person Email
romain.coriat@aphp.fr
Site Name
Maison de la Santé Protestante de Bagatelle
Department Name
hépato gastro enterology/digestive oncology
Principal Investigator Name
Julien VERGNIOL
Principal Investigator Email
j.vergniol@mspb.com
Contact Person Name
Julien VERGNIOL
Contact Person Email
j.vergniol@mspb.com
Site Name
Hospices Civils De Lyon
Department Name
Hepato-gastroenterology
Principal Investigator Name
Marion CHAUVENET
Principal Investigator Email
marion.chauvenet@chu-lyon.fr
Contact Person Name
Marion CHAUVENET
Contact Person Email
marion.chauvenet@chu-lyon.fr
Site Name
Hopital Europeen Marseille
Department Name
Digestive oncology
Principal Investigator Name
Nicolas BARRIERE
Principal Investigator Email
n.barriere@hopital-europeen.fr
Contact Person Name
Nicolas BARRIERE
Contact Person Email
n.barriere@hopital-europeen.fr
Site Name
Centre Hospitalier Loire Vendée Océan
Department Name
gastro enterology
Principal Investigator Name
Margot LALY
Principal Investigator Email
margot.laly@ght85.fr
Contact Person Name
Margot LALY
Contact Person Email
margot.laly@ght85.fr
Site Name
Clinique Belharra
Department Name
Medical Oncology
Principal Investigator Name
Marjorie FAURE
Principal Investigator Email
marjorie.faure@copb.eu
Contact Person Name
Marjorie FAURE
Contact Person Email
marjorie.faure@copb.eu
Site Name
GHBS Lorient
Department Name
Hepato-gastroenterology
Principal Investigator Name
Florence LE ROY
Principal Investigator Email
f.leroy@ghbs.bzh
Contact Person Name
Florence LE ROY
Contact Person Email
f.leroy@ghbs.bzh
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
radiology
Principal Investigator Name
Antoine BOUVIER
Principal Investigator Email
anbouvier@chu-angers.fr
Contact Person Name
Antoine BOUVIER
Contact Person Email
anbouvier@chu-angers.fr
Site Name
Hopital Saint Louis
Department Name
Hepato-gastroenterology
Principal Investigator Name
Thomas APARICIO
Principal Investigator Email
thomas.aparicio@aphp.fr
Contact Person Name
Thomas APARICIO
Contact Person Email
thomas.aparicio@aphp.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
oncology
Principal Investigator Name
Laurent MINEUR
Principal Investigator Email
l.mineur@isc84.org
Contact Person Name
Laurent MINEUR
Contact Person Email
l.mineur@isc84.org
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Principal Investigator Name
Samuel LE SOURD
Principal Investigator Email
s.lesourd@rennes.unicancer.fr
Contact Person Name
Samuel LE SOURD
Contact Person Email
s.lesourd@rennes.unicancer.fr
Site Name
CHU De Toulouse - Hopital de Rangueil
Department Name
Digestive Oncology
Principal Investigator Name
Rosine GUIMBAUD
Principal Investigator Email
guimbaud.r@chu-toulouse.fr
Contact Person Name
Rosine GUIMBAUD
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Institut Gustave Roussy
Department Name
Digestive Oncology
Principal Investigator Name
Michel DUCREUX
Principal Investigator Email
michel.ducreux@gustaveroussy.fr
Contact Person Name
Michel DUCREUX
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Oncology
Principal Investigator Name
Frédéric DI FIORE
Principal Investigator Email
Frederic.Di-Fiore@chu-rouen.fr
Contact Person Name
Frédéric DI FIORE
Contact Person Email
Frederic.Di-Fiore@chu-rouen.fr
Site Name
Fondation Hopital Saint Joseph
Department Name
oncology
Principal Investigator Name
Nabil BABA-HAMED
Principal Investigator Email
nbaba-hamed@hpsj.fr
Contact Person Name
Nabil BABA-HAMED
Contact Person Email
nbaba-hamed@hpsj.fr
Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
oncology
Principal Investigator Name
Valérie MOULIN
Principal Investigator Email
valerie.moulin@ch-larochelle.fr
Contact Person Name
Valérie MOULIN
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hepato-gastroenterology and medical oncology
Principal Investigator Name
David TOUGERON
Principal Investigator Email
david.tougeron@chu-poitiers.fr
Contact Person Name
David TOUGERON
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Clinique De L'infirmerie Protestante De Lyon
Department Name
gastro enterology
Principal Investigator Name
Johannes HARTWIG
Contact Person Name
Johannes HARTWIG
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Principal Investigator Name
Elika LOIR
Principal Investigator Email
loire@ipc.unicancer.fr
Contact Person Name
Elika LOIR
Contact Person Email
loire@ipc.unicancer.fr
Site Name
Centre Hospitalier D Avignon
Department Name
radiology
Principal Investigator Name
Adam VODNAR
Principal Investigator Email
vodnar.adam@ch-avignon.fr
Contact Person Name
Adam VODNAR
Contact Person Email
vodnar.adam@ch-avignon.fr
Site Name
Centre Leon Berard
Department Name
oncology
Principal Investigator Name
Pauline ROCHEFORT
Principal Investigator Email
pauline.rochefort@lyon.unicancer.fr
Contact Person Name
Pauline ROCHEFORT
Site Name
Hopital Haut Leveque
Department Name
Hepato-gastroenterology
Principal Investigator Name
Denis SMITH
Principal Investigator Email
denis.smith@chu-bordeaux.fr
Contact Person Name
Denis SMITH
Contact Person Email
denis.smith@chu-bordeaux.fr
Site Name
Hopital Paul Brousse
Department Name
Médical Oncology
Principal Investigator Name
Mohamed BOUCHAHDA
Principal Investigator Email
mohamed.bouchahda@pbr.aphp.fr
Contact Person Name
Mohamed BOUCHAHDA
Contact Person Email
mohamed.bouchahda@pbr.aphp.fr
Site Name
Institut de Cancérologie de l'Ouest - site de Saint Herblain
Department Name
Oncology
Principal Investigator Name
Julie VANBOCKSTAEL
Principal Investigator Email
julie.vanbockstael@ico.unicancer.fr
Contact Person Name
Julie VANBOCKSTAEL
Site Name
Hopital De La Croix-Rousse
Department Name
Hepato-gastroenterology
Principal Investigator Name
Marielle GUILLET
Principal Investigator Email
marielle.guillet@chu-lyon.fr
Contact Person Name
Marielle GUILLET
Contact Person Email
marielle.guillet@chu-lyon.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Hepato-gastroenterology
Principal Investigator Name
Jean-Baptiste BACHET
Principal Investigator Email
jean-baptiste.bachet@aphp.fr
Contact Person Name
Jean-Baptiste BACHET
Contact Person Email
jean-baptiste.bachet@aphp.fr
Site Name
Hopital Saint Joseph
Department Name
Oncology
Principal Investigator Name
Olivier MSIKA
Principal Investigator Email
omsika@hopital-saint-joseph.fr
Contact Person Name
Olivier MSIKA
Contact Person Email
omsika@hopital-saint-joseph.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepatogastroenterology
Principal Investigator Name
Julien TAIEB
Principal Investigator Email
julien.taieb@aphp.fr
Contact Person Name
Julien TAIEB
Contact Person Email
julien.taieb@aphp.fr
Site Name
Bicetre Hospital
Department Name
Hepato-gastroenterology
Principal Investigator Name
Lysiane MARTHEY
Principal Investigator Email
lysiane.marthey@aphp.fr
Contact Person Name
Lysiane MARTHEY
Contact Person Email
lysiane.marthey@aphp.fr
Site Name
Centre Hospitalier PriveSaint-Gregoire
Department Name
oncology
Principal Investigator Name
Edith CARTON
Principal Investigator Email
edith.carton@icrb.fr
Contact Person Name
Edith CARTON
Contact Person Email
edith.carton@icrb.fr
Site Name
HIA Sainte Anne
Department Name
gastro enterology
Principal Investigator Name
Caroline PRIEUX-KLOTZ
Principal Investigator Email
caroline.klotz@intradef.gouv.fr
Contact Person Name
Caroline PRIEUX-KLOTZ
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hepato-gastroenterology
Principal Investigator Name
Jean-Marc PHELIP
Principal Investigator Email
j.marc.phelip@chu-st-etienne.fr
Contact Person Name
Jean-Marc PHELIP
Site Name
Polyclinique Bordeaux Nord Aquitaine
Department Name
oncology
Principal Investigator Name
Cédric LECAILLE
Principal Investigator Email
lecail@hotmail.com
Contact Person Name
Cédric LECAILLE
Contact Person Email
lecail@hotmail.com
Site Name
Institut Bergonie
Department Name
Hepato-gastroenterology
Principal Investigator Name
Simon PERNOT
Principal Investigator Email
s.pernot@bordeaux.unicancer.fr
Contact Person Name
Simon PERNOT
Contact Person Email
s.pernot@bordeaux.unicancer.fr
Site Name
Centre Hospitalier De Perpignan
Department Name
Hepato-gastroenterology
Principal Investigator Name
Faiza KHEMISSA AKOUZ
Principal Investigator Email
faiza.khemissa@ch-perpignan.fr
Contact Person Name
Faiza KHEMISSA AKOUZ
Contact Person Email
faiza.khemissa@ch-perpignan.fr
Site Name
Centre Hospitalier Sud Francilien
Department Name
oncology
Principal Investigator Name
Samy LOUAFI
Principal Investigator Email
samy.louafi@chsf.fr
Contact Person Name
Samy LOUAFI
Contact Person Email
samy.louafi@chsf.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Principal Investigator Name
Julie VANBOCKSTAEL
Principal Investigator Email
julie.vanbockstael@ico.unicancer.fr
Contact Person Name
Julie VANBOCKSTAEL
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Hepato-gastroenterology
Principal Investigator Name
Jean-Paul LAGASSE
Principal Investigator Email
jean-paul.lagasse@chr-orleans.fr
Contact Person Name
Jean-Paul LAGASSE
Site Name
Centre Hospitalier De Pau
Department Name
Hepato-gastroenterology
Principal Investigator Name
Mireille SIMON
Principal Investigator Email
mireille.simon@ch-pau.fr
Contact Person Name
Mireille SIMON
Contact Person Email
mireille.simon@ch-pau.fr
Site Name
Hospital Foch
Department Name
oncology
Principal Investigator Name
Asmahane BENMAZIANE
Principal Investigator Email
a.benmaziane@hopital-foch.com
Contact Person Name
Asmahane BENMAZIANE
Contact Person Email
a.benmaziane@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hepato-gastroenterology
Principal Investigator Name
Sylvain MANFREDI
Principal Investigator Email
sylvain.manfredi@chu-dijon.fr
Contact Person Name
Sylvain MANFREDI
Contact Person Email
sylvain.manfredi@chu-dijon.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hepatogastroenterology
Principal Investigator Name
Franck AUDEMAR
Principal Investigator Email
faudemar@ch-cotebasque.fr
Contact Person Name
Franck AUDEMAR
Contact Person Email
faudemar@ch-cotebasque.fr
Site Name
Médipôle Hôpital Mutualiste Lyon-Villeurbanne
Department Name
Gastroenterology and Gastrointestinal oncology
Principal Investigator Name
Matthieu SARABI
Principal Investigator Email
m.sarabi@gelmad.fr
Contact Person Name
Matthieu SARABI
Contact Person Email
m.sarabi@gelmad.fr

Sponsor

Primary sponsor

Full Name
Fondation Franc.Cancerologie Digestive
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ELOXATINE 5 mg/ml, solution à diluer pour perfusion (intra-arterial presentation)
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAARTERIAL USE
Route
Intra-arterial
Authorisation Status
Authorised
Starting Dose
85 mg/m2
Dose Levels
85 mg/m2
Maximum Dose
85 mg/m2
Investigational Product Name
ELOXATINE 5 mg/ml, solution à diluer pour perfusion (intravenous presentation)
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
85 mg/m2
Dose Levels
85 mg/m2
Maximum Dose
85 mg/m2
Combination Treatment
Yes

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