Concurrent chemoradiotherapy (CRT) * Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) * ↓ ↓ ↓ ↓ ↓ * Radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 * 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea
To evaluate the pathologic response
downstaging(ypT0-2N0M0)rate
Time frame: After surgery with pathology data
Tumor regression grade & MR volumetry
To evaluate the tumor regression grade \& MR volumetry
Time frame: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery
Acute/ late toxicities
To evaluate the acute and late toxicities
Time frame: preoperative CCRT to 3 months after surgery
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