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Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Clinical Trial 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.

Clinical Trial Description

Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.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. The life quality questionnaire included QlQ-C30 and OES-18. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04519905
Study type Interventional
Source Fudan University
Contact Kuaile Zhao, doctor
Phone 18017312534
Email kuaile_z@sina.com
Status Recruiting
Phase N/A
Start date January 6, 2020
Completion date December 2027
View Details
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