Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006356
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2000-10-04
Brief Title:
Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian 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:
A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer
Detailed Description:
OBJECTIVES
Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery
Determine the toxicity of these treatment regimens in these patients
Determine the complications related to surgical treatment in these patients
Compare the quality of life in these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to stage at initial diagnosis early stage I-IIa vs advanced stage IIb-IV length of interval from end of prior first line chemotherapy 1-2 years vs more than 2 years response to first 3 courses of second line induction chemotherapy in this study no change vs partial remission vs complete remission number of measurable tumor lesions 1 vs more than 1 largest tumor size of recurrence less than 5 cm vs 5 cm or more and participating center
Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based cisplatin or carboplatin therapy Patients with no change partial remission or complete remission are randomized to one of two treatment arms
Arm I Patients undergo secondary cytoreductive surgery within 14 days of randomization Within 8 weeks after the last preoperative chemotherapy course patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity
Arm II Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I
Quality of life is assessed at baseline before the 4th or 6th course of chemotherapy or 1 week before surgery after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm and then every 6 months for up to 5 years
Patients are followed every 3 months for 2 years and then every 6 months for 3 years or until disease progression
PROJECTED ACCRUAL Approximately 700 patients will be accrued for this study within 5 years
Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery
Determine the toxicity of these treatment regimens in these patients
Determine the complications related to surgical treatment in these patients
Compare the quality of life in these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to stage at initial diagnosis early stage I-IIa vs advanced stage IIb-IV length of interval from end of prior first line chemotherapy 1-2 years vs more than 2 years response to first 3 courses of second line induction chemotherapy in this study no change vs partial remission vs complete remission number of measurable tumor lesions 1 vs more than 1 largest tumor size of recurrence less than 5 cm vs 5 cm or more and participating center
Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based cisplatin or carboplatin therapy Patients with no change partial remission or complete remission are randomized to one of two treatment arms
Arm I Patients undergo secondary cytoreductive surgery within 14 days of randomization Within 8 weeks after the last preoperative chemotherapy course patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity
Arm II Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I
Quality of life is assessed at baseline before the 4th or 6th course of chemotherapy or 1 week before surgery after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm and then every 6 months for up to 5 years
Patients are followed every 3 months for 2 years and then every 6 months for 3 years or until disease progression
PROJECTED ACCRUAL Approximately 700 patients will be accrued for this study within 5 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-55963 | None | None | None |