Chemoradiotherapy for elderly patients with esophagus cancer
Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer
This study is testing a combination of chemotherapy and radiation to see if it can safely help elderly patients over 75 with esophageal cancer who can't have surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 75 Years to 100 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Besançon) |
| Trial ID | NCT02735057 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of chemoradiotherapy in elderly patients over 75 years with esophageal cancer who are unfit for surgery. It aims to determine the maximum tolerated doses of chemotherapy and radiotherapy components, using a combination of carboplatin and paclitaxel alongside external beam radiotherapy. The study is designed in two phases, with Phase I focusing on dose determination and Phase II assessing treatment outcomes. The approach is based on previous studies that suggest carboplatin and paclitaxel may be more effective than traditional chemotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 75 years with esophageal cancer who are not suitable for surgical intervention.
Not a fit: Patients younger than 75 years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for elderly patients with esophageal cancer.
How similar studies have performed: Previous studies have shown promising results with similar chemoradiotherapy approaches, indicating potential for success in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Besançon
- Centre Hospitalier Universitaire de Besançon — Besançon, France (Recruiting)
Study contacts
- Study coordinator: Jihane BOUSTANI, Dr
- Email: jboustani@chu-besancon.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.