A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer
treated with either surgical resection or neoadjuvant.
- Compare the side effect of chemo radiotherapy according to the Common Toxicity
Criteria(CTC) version 2.0 in patients treated with these regimens.
- Compare the postoperative complications in patients treated with these regimens.
- Compare the recurrent rate in patients treated with these regimens.
- Compare the distant metastatic rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according
to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4
weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6
weeks, from 8-12 weeks after operation.
- Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and
undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI
for 7 cycles from 2-4 weeks after operation.
After completion of study treatment, patients are followed every 3 months for 2 years, and
then every 6 months for at least 3 years.
The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant
metastatic rate and 5-year survival rate will be investigated.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
5-year disease free survival
Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Ping Lan, M.D.
Sun Yat-sen University
China: Ethics Committee