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

Plain Language Summary

Simplified for easier understanding

This study is testing a combined treatment of chemotherapy and radiation therapy (chemoradiotherapy) for elderly patients age 75 and older with esophageal cancer — cancer of the tube connecting the throat to the stomach — to see if this approach is safe and effective in an older population. **You may be eligible if...** - You have been diagnosed with esophageal cancer (squamous cell or adenocarcinoma type) - Your cancer has not spread widely to distant organs - You are 75 years or older - Your general health, bone marrow, kidney, and liver function are adequate - Your overall fitness is assessed as good based on a geriatric health evaluation **You may NOT be eligible if...** - You are younger than 75 years old - Your general health is too poor to tolerate the treatment - Your organ function is not adequate for chemotherapy or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Locations(1)

Centre Hospitalier Universitaire de Besançon

Besançon, France

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NCT02735057


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