NCT04519905

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 76 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Esophageal Squamous Cell Carcinoma
• Chemoradiotherapy
• Survival

Interventions

Type	Name	Description
DRUG	Paclitaxel plus carboplatin	Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
RADIATION	radiotherapy	Different radiotherapy dose in different groups.

Timeline

• Start date: 2020-01-06
• Primary completion: 2024-12-01
• Completion: 2027-12-01
• First posted: 2020-08-20
• Last updated: 2021-11-02

Locations

3 sites across 1 country: China