Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE)

Stéphanie Servagi-Vernat, Gilles Créhange, Franck Bonnetain, Cécile Mertens, Etienne Brain, Jean François Bosset, Stéphanie Servagi-Vernat, Gilles Créhange, Franck Bonnetain, Cécile Mertens, Etienne Brain, Jean François Bosset

Abstract

Background: The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older.

Methods/design: This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO).

Discussion: This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older.

Trial registration: Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.

Keywords: Chemoradiotherapy; Clinical trial; Elderly patients; Esophageal cancer; Quality of life.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the Agence National de Sécurité du Médicament et des produits de santé (ANSM), French Ministry of Heatlh, and the Medical Ethics Committee. Written informed consent will be obtained from all participating patients.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Description of the phase I CRT dose level. Abbreviations: CRT: Chemoradiation. C: Carboplatin. P: Paclitaxel

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