A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer
- Patient is at least 18 years of age
- Good organ function
- Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum
- Evidence of distant metastases
- Contraindication for bevacizumab
- Pregnant or breastfeeding women.
Type of Study:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response (ypT0N0) rate
Outcome Time Frame:
Eric Van Cutsem, Prof. Dr.
Belgium: Federal Agency for Medicinal Products and Health Products
s51104 - ML5194
- Advanced Colorectal Cancer
- assess activity
- radiation therapy
- pre-operative treatment
- TME (total mesorectal excision).
- Colorectal Neoplasms