RecruitingPhase 1Phase 2NCT02735057

Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

54 participants

Start Date

Apr 4, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 75 YearsMax Age: 100 Years

Inclusion Criteria3

  • Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),
  • age \> 75 years,
  • WHO status \< 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.

Exclusion Criteria1

  • age \< 75 years

Interventions

DRUGCarboplatin

Locations(1)

Centre Hospitalier Universitaire de Besançon

Besançon, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02735057


Related Trials