Rectal Cancer Clinical Trial
Official title:
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
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for
resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant
therapy is still unknown.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed
by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and
postoperative chemotherapy, comparing them to see the efficacy and safety, then to
investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal
cancer.
OBJECTIVES:
Primary
- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer
treated with either surgical resection or neoadjuvant.
Secondary
- 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
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