Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003321
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
1999-11-01
Brief Title:
Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 30 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 chemoradiotherapy vs radical radiotherapy with or without chemotherapy Patients receiving purely palliative treatment are further stratified according to study treatment intubationlaserethanol injection vs palliative chemoradiotherapy without endoscopic relief of dysphagia Patients are administered two questionnaires 1 The EORTC QLQ-C30 version 30 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
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 chemoradiotherapy vs radical radiotherapy with or without chemotherapy Patients receiving purely palliative treatment are further stratified according to study treatment intubationlaserethanol injection vs palliative chemoradiotherapy without endoscopic relief of dysphagia Patients are administered two questionnaires 1 The EORTC QLQ-C30 version 30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-1596140973 | None | None | None |