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Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Sponsor: Fudan University
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.
Key Details
Gender
All
Age Range
76 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2020-01-06
Completion Date
2027-12
Last Updated
2021-11-02
Healthy Volunteers
No
Interventions
Paclitaxel plus carboplatin
Paclitaxel (45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapy
Different radiotherapy dose in different groups.
Locations (3)
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China