The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a (according to AJCC2002) Scheme: Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio. Arm Cisplatin: Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles. Arm Paclitaxel: Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
436
5-fluorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-fluorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
3-yr overall survival
Time frame: 3 years
Disease progression-free survival
Time frame: 3 years
Local progression-free survival
Time frame: 3 years
Number and grade of Participants with Adverse Events
Time frame: 6 months
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A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.