Status:
RECRUITING
Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of t...
Eligibility Criteria
Inclusion
- Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
- At least one measurable hepatic metastasis according to the criteria RECIST v1.1
- No other metastatic sites except lung nodules if number ≤ 3 and \< 10 mm
- RAS mutation status known (determination of KRAS mutation (exons 2,3 and 4) and determination of the NRAS mutation (exons 2,3 and 4))
- Age ≥ 18
- WHO ≤ 2 (Appendix 4)
- No prior treatment by chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
- Life expectancy \> 3 months
- PNN \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dLq
- Bilirubin \< 25 mmol/L, AST \< 5x ULN, ALT \< 5 x ULN, ALP \< 5 x ULN, TP \> 60%, proteinuria from 24H \< 1 g
- Creatinine clearance \> 50 mL/min according to MDRD formula (Appendix 4)
- Patient affiliated to a social security scheme
- Patient information and signature of the informed consent
Exclusion
- Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
- Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
- 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, intra-abdominal 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
- Transplant patients, HIV positive or other immune deficiency syndromes
- Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
- Peripheral neuropathy \> 1
- Patient with interstitial pneumonitis or pulmonary fibrosis
- History of chronic diarrhea or inflammatory disease of the 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 considered in complete remission or in situ cervical carcinoma, properly treated
- Patient already included in another clinical trial with an experimental molecule
- Any known specific contraindication or allergy or hypersensitivity to the drugs used in the study (cf RCP Appendix 7)
- Known deficit in DPD
- QT/QTc range \> 450 msec for men and \> 470 msec for women
- K+ \< LNL, Mg2+ \< LNL, Ca2+ \< LNL
- 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
- Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT02885753
Start Date
December 1 2016
End Date
September 1 2028
Last Update
July 9 2025
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Erasme
Brussels, Belgium
2
Chu Hotel Dieu
Angers, France
3
Institut de Cancérologie de l'Ouest
Angers, France
4
Hôpital Privé d'Antony
Antony, France