Trial name or title |
A Randomized Phase II Study to Investigate the Deepness of Response of FOLFOXIRI Plus Cetuximab (Erbitux) Versus FOLFOXIRI Plus Bevacizumab as the First‐line Therapy in Metastatic Colorectal Cancer Patients With RAS Wild‐type Tumors: DEEPER |
Methods |
Phase II open‐label, randomised study |
Participants |
People with RAS WT mCRC |
Interventions |
Experimental: the combination of FOLFOXIRI and cetuximab. Comparator: the combination of FOLFOXIRI and bevacizumab |
Outcomes |
Primary outcome: best depth of response. Secondary outcomes: rate of tumour shrinkage at 8 weeks, response rate, deepness of response, OS, PFS, rate of curative resection of metastases, number of adverse events |
Starting date |
August 2015 |
Contact information |
Toshifusa Nakajima, MD, Japan Clinical Cancer Research Organization |
Notes |
JPRN‐UMIN000018412 is the adjunct biomarker study to DEEPER. |