drugset / Trial / NCT04519905
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Recruiting
320 enrolled
Fudan University
Fujian Cancer Hospital · collabGansu Cancer Hospital · collabHuadong Hospital · collabJiangsu Cancer Institute & Hospital · collabNingbo No.2 Hospital · collabTaihe Hospital · collabThe First Affiliated Hospital of Xiamen University · collabWuxi No. 4 People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Timeline
- Start
- 2020-01-06
- Primary completion
- 2024-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | 45 mg/m2 | — |