Trial Information

An International Field Study of the Reliability and Validity of the EORTC-QLQ-C30 and a Disease Specific Questionnaire Module (the EORTC OES-24) in Assessing the Quality of Life of Patients With Oesophageal Cancer

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.