An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy
Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
Radiotherapy for 5-6 weeks,50-60Gy
Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
SYSU Cancer Center
Guangzhou, Guangdong, China
Overall objective response rate
The proportion of partial and complete remission of tumors
Time frame: up to 24 months
Incidence of toxic and side effects above 3 degrees
The Incidence of toxic and side effects above 3 degrees in overall patients
Time frame: up to 24 months
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