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Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

RECRUITINGPhase 1/2Sponsored by Centre Hospitalier Universitaire de Besancon
Actively Recruiting
PhasePhase 1/2
SponsorCentre Hospitalier Universitaire de Besancon
Started2016-04-04
Est. completion2028-11-16
Eligibility
Age75 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT02735057

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

Age: 75 Years – 100 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* age \< 75 years

Conditions3

CancerElderly PatientsOesophagus Cancer

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