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Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
Sponsor: China Medical University Hospital
Summary
Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer. Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT. The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1. The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.
Official title: Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-01
Completion Date
2028-10-30
Last Updated
2024-09-19
Healthy Volunteers
No
Interventions
S-1
Treatment schedule At 4 to 8 weeks after chemotherapy and radiotherapy ended, maintenance S-1 was administered for up to 12 cycles. A cycle was 3 weeks, with S-1 administrated on days 1 to 14 in each cycle. The initial dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA \< 1.25 m2; 50 mg twice a day for 1.25 m2⩽ BSA \< 1.5 m2; and 60 mg twice a day for BSA ⩾1.5 m2. Maintenance chemotherapy with S1 was administered for 12 cycles or terminated earlier if there was disease progression, intolerable toxicity, or at the patient's request.