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PRODIGE 49 - OSCAR: Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 ± Irinotecan, and targeted therapy, in first-line treatment of metastatic colorectal cancer restricted to the liver
EU CTIS ID: 2024-518553-41-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
- 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
- Creatinine clearance > 50 mL/min according to MDRD formula
- Patient affiliated to a social security scheme
- Patient information and signature of the informed consent
- At least one measurable hepatic metastasis according to the criteria RECIST v1.1
You likely can't join if
- Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
- Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
- Peripheral neuropathy > 1 (NCI CT v4.0)
- Patient with interstitial pneumonitis or pulmonary fibrosis
- History of chronic diarrhea or inflammatory disease of the intestine, colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
- History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
See the full eligibility criteria
- Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
- 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
- Creatinine clearance > 50 mL/min according to MDRD formula
- Patient affiliated to a social security scheme
- Patient information and signature of the informed consent
- At least one measurable hepatic metastasis according to the criteria RECIST v1.1
- No other metastatic sites except lung nodules accepted if number ≤ 3 and < 10 mm
- RAS mutation status known (determination of KRAS mutation [exons 2,3 and 4]and NRAS [exons 2,3 and 4])
- Age ≥ 18
- OMS ≤ 2
- 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)
- Life expectancy > 3 months
- PNN > 1500 /mm3, platelets > 100 000/mm3, Hb > 9 g/dL
- Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
- Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
- Peripheral neuropathy > 1 (NCI CT v4.0)
- Patient with interstitial pneumonitis or pulmonary fibrosis
- History of chronic diarrhea or inflammatory disease of the intestine, colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
- History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
- Patient already included in another clinical trial with an experimental molecule
- Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)
- Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)
- QT/QTc range > 450 msec for men and > 470 msec for women
- K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
- Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
- 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
- Persons deprived of liberty or under supervision
- Information du patient et signature du consentement éclairé
- 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
- 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)
- A history of abdominal fistula, gastrointestinal perforation, intraabdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
- Progressive gastroduodenal ulcer, wound or fractured bone
- Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
- 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
- Transplant patients, HIV positive or other immune deficiency syndromes
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.