drugset / Trial / NCT03708042
A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer
Phase 3
Unknown
220 enrolled
Tianjin Medical University Cancer Institute and Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabPeking University Cancer Hospital & Institute · collabSun Yat-sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase Ⅲ multicenter clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response (CCR) after neoadjuvant radiochemotherapy for resectable locally advanced esophageal cancer.
Timeline
- Start
- 2018-12-01
- Primary completion
- 2021-12-01
- Completion
- 2023-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Background | Docetaxel | Small molecule | 25 mg/m2 | — |