Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in
5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered
concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of
downstaing is the study endpoint.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the pathologic response
downstaging(ypT0-2N0M0)rate
After surgery with pathology data
No
Korea: Institutional Review Board
NCCCTS-10-458
NCT01129700
February 2010
February 2012
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