Metastatic Colorectal Cancer
Conditions
Keywords
metastatic colorectal cancer, FOLFOX 6, FOLFIRI
Brief summary
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Detailed description
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC. EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively. Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
Interventions
DRUGCetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
DRUGFOLFOX 6
FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
DRUGFOLFIRI
FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Sponsors
Central European Cooperative Oncology Group
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
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * Metastatic colorectal carcinoma not suitable for curative-intent resection * Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment * Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area) * ECOG performance status of \< 2 at study entry
Exclusion criteria
* Brain metastasis (known or suspected) * Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months * Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry * Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to EGFR-pathway targeting therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of patients surviving without disease progression in each arm at 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS rates at 3,6,12 months | — |
| Response rates | — |
| Overall survival (OS) in each arm | — |
| Safety | — |
Countries
Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Hungary, Israel, Portugal, Romania, Slovakia, Slovenia, Turkey (Türkiye)
Outcome results
None listed