Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004909
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2000-03-07
Brief Title:
Effect of Chemotherapy Given Either by Mouth or by Infusion on the Quality of Life of Patients With Recurrent Ovarian Epithelial Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
The Impact of Oral Chemotherapy on Quality of Life in Patients With Recurrent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2011-02
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 Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of the treatment on these patients
PURPOSE This clinical trial studies the effects of chemotherapy given by mouth versus chemotherapy given by infusion on quality of life in patients with recurrent ovarian epithelial cancer
PURPOSE This clinical trial studies the effects of chemotherapy given by mouth versus chemotherapy given by infusion on quality of life in patients with recurrent ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine the impact of oral versus parenteral chemotherapy on quality of life QOL in patients with recurrent ovarian epithelial cancer II Evaluate the QOL over time in this patient population III Determine the impact of disease symptoms treatment side effects performance status and CA-125 levels on QOL assessment in this patient population
OUTLINE Patients receive a baseline quality of life QOL assessment an attitudespreference survey and a performance status assessment at the time of diagnosis of recurrent disease Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines prior treatment history and patient preference QOL and performance status assessments are obtained again at 3 and 6 months during treatment Attitudespreferences are assessed at 6 months Patients are withdrawn from study if treatment regimen is changed from oral to IV or from IV to oral during this 6 months
PROJECTED ACCRUAL A total of 74 patients will be accrued for this study over 12 months
OUTLINE Patients receive a baseline quality of life QOL assessment an attitudespreference survey and a performance status assessment at the time of diagnosis of recurrent disease Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines prior treatment history and patient preference QOL and performance status assessments are obtained again at 3 and 6 months during treatment Attitudespreferences are assessed at 6 months Patients are withdrawn from study if treatment regimen is changed from oral to IV or from IV to oral during this 6 months
PROJECTED ACCRUAL A total of 74 patients will be accrued for this study over 12 months
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 |
|---|---|---|---|
| NCI-G00-1694 | None | None | None |
| NU-98Q3 | None | None | None |