Clinical Trial

Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

Study acronym: OSAGE
Recruiting Phase 1/2
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Summary
Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing. Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2016-04-06; most recent amendment 2024-01-17.
Status change: Not Yet Recruiting → Recruiting 2017-04-14
Trial Details
NCT Number NCT02735057
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Conditions Oesophagus Cancer, Elderly Patients
Enrollment 54 participants
Start Date 2016-04-04
Primary Completion 2028-11-16 (estimated)
Study Completion 2029-05-16 (estimated)
Updated on ClinicalTrials.gov 2024-01-18