The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
1.1 experimental arm Two-week course concurrent chemoradiotherapy * Radiotherapy, 33 Gy/10 fractions for 2 weeks ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12 * Capecitabine 825 mg/m2, twice daily 1.2 control arm Standard concurrent chemoradiotherapy (CRT) * Radiotherapy, 50.4 Gy/28 fractions for 6 weeks ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38 * Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5 * Capecitabine, 825 mg/ m2, bid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
370
33 Gy in 10 fractions for 2 weeks
oral capecitabine, 825mg/m2, bid
Lee Jong Hoon
Suwon, South Korea
RECRUITINGTumor response from stage II-III to stage 0-I
Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)
Time frame: from clinical staging time to radical surgery date (about 3 months)
Toxicity (acute and chronic)
During the course of radiotherapy, patients were evaluated weekly to assess acute toxicity. Patients were also followed 2 and 4 weeks after completion of radiotherapy and until 3 years after curative surgery to assess toxicity. Toxicity are assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Time frame: from radiation start to 3 years after radical surgery
Recurrence and survival
Time frame: 3-year recurrence-free survival and 3-year overall survival
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