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

Phase 1

• Conditions: colorectal cancer with hepatic metastasis; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002393-12-BE
• Lead Sponsor: Fédération Francophone de Cancérologie Digestive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 348

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 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/dLq
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 228

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 (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
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified