Neoadjuvant Radiotherapy Combined With Capecitabine and Sorafenib in Patients With Advanced, K-ras Mutated Rectal Cancer. A Multicenter Phase I/IIa Trial.
- Determine the recommended dose of neoadjuvant capecitabine when given together with
sorafenib tosylate and external-beam radiotherapy in patients with K-ras mutated,
locally advanced rectal cancer. (Phase I)
- Assess the efficacy and safety of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of capecitabine followed by a
phase II study.
Patients receive oral capecitabine twice daily and oral sorafenib tosylate once daily on
days 1-33. Patients also undergo external-beam radiotherapy once daily on days 1-5, 8-12,
15-19, 22-26, and 29-33. Approximately 6 weeks after completion of neoadjuvant therapy,
patients undergo surgery.
After completion of study therapy, patients are followed at 8 weeks and then periodically
for up to 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity of the treatment combination (Phase I)
during trial treatment (12 weeks)
Roger von Moos, MD