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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - age \< 75 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Carboplatin

Locations (1)

Centre Hospitalier Universitaire de Besançon
Besançon, France