Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020826
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2001-07-11
Brief Title:
Assessing Quality of Life of Patients With Stomach Cancer
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 QLQ-STO22 In Assessing The Quality Of Life Of Patients With Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients
PURPOSE Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer
PURPOSE Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer
Detailed Description:
OBJECTIVES
Determine the scale structure reliability and validity of the tumor-specific questionnaire QLQ-STO22 in assessing the quality of life of patients with gastric cancer
Determine the questionnaires sensitivity to change in clinical health status in these patients
OUTLINE Patients are stratified according to type of treatment potentially curative vs potentially palliative disease stage local and locoregional vs metastatic Karnofsky performance status less than 80 vs more than 80 and initial weight gain none vs less than 10 of total body weight vs 10 or more of total body weight
Curatively Treated Group Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent at 4 weeks prior to chemotherapy andor radiotherapy 4 weeks prior to surgery and 3 months after surgery in patients receiving neoadjuvant chemotherapy andor radiotherapy followed by total or partial gastrectomy with curative intent at 4 weeks prior to chemotherapy andor radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy andor radiotherapy following total or partial gastrectomy and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection
Palliatively Treated Group Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy
PROJECTED ACCRUAL Approximately 220 patients 110 per group will be accrued for this study within 2 years
Determine the scale structure reliability and validity of the tumor-specific questionnaire QLQ-STO22 in assessing the quality of life of patients with gastric cancer
Determine the questionnaires sensitivity to change in clinical health status in these patients
OUTLINE Patients are stratified according to type of treatment potentially curative vs potentially palliative disease stage local and locoregional vs metastatic Karnofsky performance status less than 80 vs more than 80 and initial weight gain none vs less than 10 of total body weight vs 10 or more of total body weight
Curatively Treated Group Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent at 4 weeks prior to chemotherapy andor radiotherapy 4 weeks prior to surgery and 3 months after surgery in patients receiving neoadjuvant chemotherapy andor radiotherapy followed by total or partial gastrectomy with curative intent at 4 weeks prior to chemotherapy andor radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy andor radiotherapy following total or partial gastrectomy and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection
Palliatively Treated Group Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy
PROJECTED ACCRUAL Approximately 220 patients 110 per group will be accrued for this study within 2 years
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-40003 | OTHER | EORTC | None |
| EORTC-15001 | OTHER | None | None |