Highlighted Trial -- CRC.5
|CRC.5 - A Phase III Trial of Irinotecan/5-FU/Leucovorin (FOLFIRI) or Oxaliplatin/5-FU/Leucovorin (FOLFOX) with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum -- was centrally activated in March 2008.
This is the priority North American Intergroup trial for first-line metastatic colorectal cancer. It is a 3-arm trial that compares FOLFOX or FOLFIRI (investigator's choice) and bevacizumab vs FOLFOX or FOLFIRI + cetuximab vs FOLFOX or FOLFIRI + cetuximab and bevacizumab.
Only KRAS "wild type" patients will be eligible. The sample size for the trial is 2850, and 1458 patients have been accrued at U.S. centres to date.
This trial is particularly important for two reasons:
1. It is the only large randomized trial to compare Chemotherapy + Bevacizumab to Chemotherapy + Cetuximab. It is powered to assess a survival difference between these two arms and between Chemotherapy + Bevacizumab vs Chemotherapy + double biologics.
2. Despite the disappointing results of the CAIRO2 and PACCE trials, only a minority of patients in PACCE (230) and none in CAIRO2 received Irinotecan-based chemotherapy and double biologic therapies. CRC.5 is the only trial that will be able to definitively determine whether double biologic therapy and FOLFIRI improves outcome with FOLFIRI and either biologic alone in K-Ras wild type patients. This will be by far the largest trial including Irinotecan-based chemotherapy and double biologic therapies for the first-line treatment of metastatic colorectal cancer. Because of its size and associated correlative studies, it will also allow analyses that could help determine which patients benefit from these studies.
Bevacizumab will be supplied at no charge to Canadian centres (with no pre-specified restriction on either the number of cycles funded or the choice of combination chemotherapy used with bevacizumab) along with cetuximab.
The provincial OCREB application will be submitted on March 29, so investigators in Ontario will only need to complete the centre OCREB application.
Per case funding for this trial is $4000 USD.
If you have any questions about CRC.5, please contact Patrick Smith, Study Coordinator, at email@example.com.