Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
NCT05775419 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1216
Last updated 2023-03-20
Summary
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
Conditions
- Esophageal Squamous Cell Carcinoma
- Chemotherapy Effect
- Side Effect of Drug
Interventions
- COMBINATION_PRODUCT
-
Consolidation chemotherapy (4 courses)
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen;
- COMBINATION_PRODUCT
-
Concurrent chemotherapy (2 courses)
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week\*2cycles; DDP 75mg/m2 ivgtt, d2, 3week\*2cycles;
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Xiaolin GE, MM · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2025-06-30
- Completion
- 2028-06-30
Countries
- China
Study Locations
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