Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
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- STATUS
- Recruiting
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- End date
- Jun 30, 2028
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- participants needed
- 1216
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- sponsor
- The First Affiliated Hospital with Nanjing Medical University
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.
Description
Test grouping:
Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;
Specific chemotherapy regimens:
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week2cycles; DDP 75mg/m2 ivgtt, d2, 3week2cycles; 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; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life
Details
| Condition | Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug |
|---|---|
| Treatment | Consolidation chemotherapy (4 courses), Concurrent chemotherapy (2 courses) |
| Clinical Study Identifier | NCT05775419 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Last Modified on | 11 April 2023 |
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