drugset / Trial / NCT03366883
Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
Phase 3
Unknown
420 enrolled
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Chongqing Medical University · collabHenan Cancer Hospital · collabShanghai Chest Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital with Nanjing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
Timeline
- Start
- 2018-02-01
- Primary completion
- 2018-02-04
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 45 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | — |