Neoadjuvant Radiotherapy and Capecitabine With or Without Panitumumab in Patients With Advanced, K-ras Unmutated Rectal Cancer. A Randomized Multicenter Phase II Trial
- To assess the efficacy and safety of neoadjuvant capecitabine and concurrent
3-dimensional conformal radiotherapy with vs without panitumumab in patients with
advanced K-ras unmutated rectal cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, T stage (T3 vs T4), tumor localization measured from caudal part of the tumor to the
anocutaneous line (< 10 cm vs ≥ 10 cm), and number of EGFR gene copies (< 2.9 vs ≥ 2.9).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive panitumumab IV over 30-90 minutes on days 1, 15, 29, 43, and 57
and oral capecitabine twice daily on days 8-40. Beginning on day 8, patients undergo
daily fractions of 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning
approximately 6 weeks after completion of panitumumab and chemoradiotherapy, patients
- Arm II: Patients receive oral capecitabine twice daily on days 1-33. Patients undergo
concurrent 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning 6 weeks
after completion of chemoradiotherapy, patients undergo surgery.
After completion of study therapy, patients are followed periodically for up to 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological complete or near-complete response (Dworak grade 3 and 4)
after 13 weeks.
Daniel Helbling, MD