MedDRA version: 19.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Fédération Francophone de Cancérologie Digestive
Eligibility
Sex/Gender
All
Inclusion 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 accepted if number = 3 and 3 months - PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dLq - Total bilirubin 60%, proteinuria from 24H 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 168
Exclusion criteria
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 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) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of hepatic progression free survival in each arm. Hepatic progression was assessed according to the criteria RECIST v1.1 and according to the investigator.;Secondary Objective: -Toxicities according to NCI-CTC v4.0 -Evaluation of the best response under treatment, and progression-free survival (radiation only) after central review of the X-rays -Best answer obtained under treatment according to the investigator -Overall survival (median) -Progression free survival (clinical and/or radiological) (median) -Evaluation of quality of life (QLQ-C30) -Early tumor response rate (response > 20%) at 8 weeks -Response depth -Secondary resection rate -Histological response in case of secondary resection -Evolution of the tumor marker (CEA) ;Primary end point(s): Hepatic progression free survival (median);Timepoint(s) of evaluation of this end point: To evaluate the primary end point we need to have 228 events (hepatic progression or death) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival (clinical and/or radiological) (median) - Evaluation of quality of life (QLQ-C30) - Toxicities according to NCI-CTC v4.0 - Early tumor response rate (response > 20%) at 8 weeks - Response depth - Evaluation of the best response under treatment, and progression-free survival (radiation only) after central review of the X-rays - Best answer obtained under treatment according to the investigator - Histological response in case of secondary resection - Evolution of the tumor marker (CEA) ;Timepoint(s) of evaluation of this end point: To evaluate the secondary end points we need to have 228 events (hepatic progression or death) | — |
Countries
Belgium, France
Contacts
Public ContactChef de projets
Fédération Francophone de Cancérologie Digestive
Outcome results
None listed