Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, cetuximab, maintenance
Brief summary
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
Interventions
DRUGCetuximab
DRUGFOLFIRI and cetuximab
Sponsors
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed colorectal cancer 2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis 3. Non resectable metastatic disease in a curative intent 4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion 5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated 6. Life expectancy above 3 months 7. Performance Status ≤2 (WHO) 8. Patient ≥18 years-old 9. Acceptable blood test 10. Patient having signed a written informed consent form
Exclusion criteria
1. Known and/or symptomatic brain metastases 2. Known allergy to one of treatment components 3. Neurological or psychiatric condition which could interfere with good treatment compliance 4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation 5. Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan 6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization 7. Concomitant severe infection 8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.) 9. Patient already included in another clinical trial with an investigational molecule 10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®) 11. Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment 12. Those deprived of their freedom or under guardianship 13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival at 6 months | 6 months after start of maintenance therapy | Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause |
Countries
France
Outcome results
None listed