Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003695
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Trial of Interval Debulking Surgery in Epithelial Ovarian Cancer Suboptimally Debulked at Primary Surgery
Status:
COMPLETED
Status Verified Date:
2007-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with surgery may kill more tumor cells It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage II or stage III ovarian cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer
Detailed Description:
OBJECTIVES I Determine the impact of interval debulking surgery in terms of survival disease-free survival and quality of life in patients with newly diagnosed stage II or III ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery
OUTLINE This is a randomized study of debulking surgery with concurrent chemotherapy Patients are randomized to receive chemotherapy alone arm I or chemotherapy and interval debulking surgery arm II Arm I Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks Arm II Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks In the absence of disease progression patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy Surgery is then immediately followed by three additional courses of platinum-based chemotherapy Patients are followed at 6 months after randomization then every 3 months for the remainder of the first 2 years then every 6 months for the following 3 years and then annually thereafter Quality of life is assessed prior to randomization and before the fourth course of chemotherapy and then at follow-up visits at 6 months and 1 2 and 3 years
PROJECTED ACCRUAL There will be 1000 patients accrued into this study
OUTLINE This is a randomized study of debulking surgery with concurrent chemotherapy Patients are randomized to receive chemotherapy alone arm I or chemotherapy and interval debulking surgery arm II Arm I Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks Arm II Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks In the absence of disease progression patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy Surgery is then immediately followed by three additional courses of platinum-based chemotherapy Patients are followed at 6 months after randomization then every 3 months for the remainder of the first 2 years then every 6 months for the following 3 years and then annually thereafter Quality of life is assessed prior to randomization and before the fourth course of chemotherapy and then at follow-up visits at 6 months and 1 2 and 3 years
PROJECTED ACCRUAL There will be 1000 patients accrued into 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 |
|---|---|---|---|
| EU-98063 | None | None | None |
| MRC-OV06 | None | None | None |