NCT02735057RecruitingPhase 1/2
Chemoradiotherapy in Elderly Patients With Oesophagus Cancer
Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer
Source: ClinicalTrials.gov · Last updated 18 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 18 Mar 2016
- Start date
- 4 Apr 2016
- Primary completion date
- 16 Nov 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02735057
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 54
- From 4 Apr 2016 to the primary completion date, 16 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- age \< 75 years
Who the study is looking for
- 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.
Age in the registry: 75 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.