Status:
COMPLETED
Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases
Lead Sponsor:
UNICANCER
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targete...
Eligibility Criteria
Inclusion
- Histologically proven colorectal adenocarcinoma,
- Primary tumor of the colon or rectum, resectable or resected at least 3 weeks before randomization or 4 weeks before the beginning of the study treatment,
- Metastatic disease with synchronous or metachronous (\> 3 months after diagnosis of the primary tumor) hepatic metastasis,
- Non-resectable (with respect to curative intent) hepatic metastasis at presentation. This criterion must be validated by both a surgeon and a radiologist during the RCP (Multidisciplinary cancer case presentation committee) patient's evaluation meeting (either technically non-resectable metastases (absolute contraindication): i.e. impossibility to resect all metastases in a single operation while preserving at least 30% of healthy liver tissues and/or impossibility to preserve the portal vein and hepatic artery homolateral to the liver or a portal pedicle, or due to oncological non-resectability (relative contraindication): presence of \> 5 nodules and bilateral invasion),
- Hepatic metastases, without spread to other sites except in case of ≤ 3 resectable pulmonary metastases of diameter \< 2 cm, detected by thoracic scanner,
- K-Ras status determined before randomization,
- Measurable disease according to the RECIST V1.1 criteria,
- No prior treatment of the hepatic metastases,
- Previous 5FU +/- oxaliplatin-based adjuvant chemotherapy administered after colorectal tumor resection is authorized if complete more than 1 year before,
- Age ≥ 18 \& ≤ 75 years
- Performance status : ECOG 0 or 1,
- Life expectancy ≥ 3 months,
- Hemoglobin ≥ 9 g/dl,
- Polynuclear neutrophiles ≥ 1500/mm3,
- Platelets ≥ 100 000 mm3,
- Creatinemia ≤ 135 µmol/l (1,35 mg/dl)
- Total bilirubin ≤ 1.25 times the Upper Limit of Normal (ULN).
- Hepatic enzymes ASAT and ALAT \< 5 x ULN,
- Negative pregnancy test for women of child-bearing age,
- Information given to the patient and signed informed consent,
- Public Health insurance coverage.
Exclusion
- Non metastatic and/or non measurable disease according to the RECIST v1.1 criteria.
- Non-resectable primary tumor (e.g.: T4 tumors) or incomplete resection R2.
- History of intestinal inflammatory disease.
- Specific contraindication to any of the study treatments.
- Patient who have previously received anti-EGFr (e.g., cetuximab) or anti-VEGF monoclonal antibody treatment (e.g., bevacizumab) or treatment with irinotecan.
- History of cancer considered as not cured.
- Stroke/CVA or pulmonary embolism within 6 months before inclusion.
- Significant concomitant disease such as: coagulopathy, respiratory or cardiac congestive insufficiency, non-medically controlled/unstable angina pectoris, myocardial infarction within 6 months prior to study entry, arterial hypertension and uncontrolled arrhythmia, severe infections.
- Clinical neuropathy, grade ≥1.
- Patient already included in another therapeutic trial using an experimental molecule.
- Pregnant women or women who might become pregnant during the study or lactating women.
- Men or women who can procreate and who do not abide with the use of a contraceptive means.
- Persons kept in detention or incapable of giving consent
- Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic social or psychological reasons.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01442935
Start Date
February 1 2011
End Date
January 1 2021
Last Update
June 18 2021
Active Locations (1)
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1
Centre Val d'Aurelle
Montpellier, France, 34298