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

Launched by FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE · Aug 26, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a combination of different chemotherapy treatments for patients with colorectal cancer that has spread to the liver and cannot be surgically removed. The goal is to see if using a specific treatment strategy, which includes both systemic (whole-body) chemotherapy and targeted therapies, can improve how well the cancer responds and potentially extend survival for these patients. The trial is currently recruiting participants who are at least 18 years old, have a confirmed diagnosis of colorectal cancer with liver metastases, and meet other health criteria.

Eligible participants can expect to receive a combination of treatments that may include chemotherapy delivered directly to the liver, which could reduce side effects compared to traditional methods. While early results from similar treatments show promising outcomes, it's important to note that this study is still in the recruitment phase, and the treatment approach has not yet been widely adopted in standard practice. Participants will be closely monitored throughout the trial to ensure their safety and evaluate the effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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