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Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

Study acronym: OSAGE
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 2024 to Nov 16, 2028
    • Study completion date: Apr 2026 to May 16, 2029
    • Start date: Apr 2016 to Apr 4, 2016
    v7
  2. Site contact updatedv6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Apr 2016 to Nov 2024
    • Study completion date: Apr 2024 to Apr 2026
    • Site contact updated
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Apr 2018 to Apr 2016
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02735057
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Conditions
(from sponsor)		 Oesophagus Cancer, Elderly Patients
Related terms Esophageal Neoplasms
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov