Clinical trial · Interventional
Chemoradiotherapy in Elderly Patients With Oesophagus Cancer
Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elderly Patients | — | UNRESOLVED | — |
| Oesophagus Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase I
- description
- * for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2) * for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
- interventionNames
- Drug: Carboplatin
Primary outcomes (1)
- measure
- maximum tolerated dose (MTD)
- timeFrame
- 1 months after the end of the treatment
- description
- the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II.The phase I is conducted with increasing doses of each component with 9 levels.Step definitively stopped in case of any grade ≥ 3 or severe acute toxicities. In case a step is definitively stopped, add 3 more patients to the precedent step. Quality assurance
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDServagi-Vernat S, Crehange G, Bonnetain F, Mertens C, Brain E, Bosset JF. Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE). BMC Cancer. 2017 Jul 13;17(1):483. doi: 10.1186/s12885-017-3465-4. PMID 28705182