Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT00003321
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients who have cancer of the esophagus.

PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of the esophagus who are receiving treatment.

Detailed Description

OBJECTIVES: I. Test the psychometric, clinical, and cross cultural validity and reliability of the quality-of-life questionnaire EORTC-QLQ-C30 (version 3.0) in conjunction with the esophageal cancer-specific module EORTC QLQ-OES-24 in patients with esophageal cancer.

OUTLINE: This is a multicenter study. Patients are stratified by treatment (potentially curative vs purely palliative). Patients receiving potentially curative treatment are further stratified according to study treatment (esophagectomy alone vs esophagectomy plus adjuvant or neoadjuvant chemo/radiotherapy vs radical radiotherapy with or without chemotherapy). Patients receiving purely palliative treatment are further stratified according to study treatment (intubation/laser/ethanol injection vs palliative chemo/radiotherapy without endoscopic relief of dysphagia). Patients are administered two questionnaires: (1) The EORTC QLQ-C30 (version 3.0) is a 30-item questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. (2) The EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer. Both questionnaires are administered once before and once during or after treatment.

PROJECTED ACCRUAL: 370 patients (170 with locoregional disease, 200 with metastatic disease) will be accrued for this study.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-08
• Study First Submitted QC: 2004-03-19
• Study First Posted: 2004-03-22
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Clinique Armoricaine De Radiologie; 🇫🇷 Saint Brieux, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Sir Charles Gairdner Hospital, Perth; 🇦🇺 Perth, Western Australia, Australia

Robert Roessle Klinik; 🇩🇪 Berlin, Germany

University of Marburg; 🇩🇪 Marburg, Germany

Diakonissehjemm Ets University Hospital; 🇳🇴 Bergen, Norway

Hospital De Navarra; 🇪🇸 Pamplona, Spain

Sahlgrenska University Hospital; 🇸🇪 Gothenburg (Goteborg), Sweden

Hopital Cantonal Universitaire de Geneva; 🇨🇭 Geneva, Switzerland

Bristol Royal Infirmary; 🇬🇧 Bristol, England, United Kingdom