Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003381
Status:
TERMINATED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer Companion to CALGB-9781
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer Companion to CALGB-9781
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
companion study to CALGB-9781 which closed administratively due to poor accrual
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 during treatment may improve the ability to plan treatment for patients with esophageal cancer
PURPOSE This clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer
PURPOSE This clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer
Detailed Description:
OBJECTIVES I Evaluate the quality of life of patients with esophageal cancer randomized on protocol CALGB C9781 to treatment with surgery alone vs trimodal therapy combining preoperative chemotherapy and radiation therapy in addition to surgery II Examine the incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer III Examine the incremental cost per quality-adjusted life year QALY of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer
OUTLINE This is a companion study to CALGB C9781 a phase III randomized study Prior to treatment on CALGB C9781 patients complete forms assessing quality of life psychological functioning specific areas of dysfunction resource use and time lost from work subsequent assessments are completed by telephone interview at 1 2 6 12 18 and 24 months after the initiation of study treatment regardless of disease status patients with hearing impairment and those speaking only a translatable foreign language may mail responses Patients also keep a diary of medical resource utilization at sites other than the treating institution
OUTLINE This is a companion study to CALGB C9781 a phase III randomized study Prior to treatment on CALGB C9781 patients complete forms assessing quality of life psychological functioning specific areas of dysfunction resource use and time lost from work subsequent assessments are completed by telephone interview at 1 2 6 12 18 and 24 months after the initiation of study treatment regardless of disease status patients with hearing impairment and those speaking only a translatable foreign language may mail responses Patients also keep a diary of medical resource utilization at sites other than the treating institution
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 |
|---|---|---|---|
| CDR0000066376 | REGISTRY | NCI Physician Data Query | None |