Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002568
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A PHASE III RANDOMIZED STUDY OF CISPLATIN NSC 119875 AND TAXOL PACLITAXEL NSC 125973 WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III IV EPITHELIAL OVARIAN CARCINOMA
Status:
COMPLETED
Status Verified Date:
2010-05
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 more than one drug or combining chemotherapy with surgery may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxelcisplatin II Determine the morbidity of secondary cytoreductive surgery in these patients III Assess prospectively the quality of life QOL of these patients and determine whether secondary cytoreductive surgery affects QOL
OUTLINE Randomized study Following treatment on Regimen A patients with stable or objective response are randomized to Arms I and II Regimen A 2-Drug Combination Chemotherapy Paclitaxel Bristol-Myers Taxol NSC-125973 Cisplatin CDDP NSC-119875 Arm I Surgery followed by 2-Drug Combination Chemotherapy Laparotomy with resection of residual disease followed by TaxolCDDP Arm II 2-Drug Combination Chemotherapy Taxol CDDP
PROJECTED ACCRUAL Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients
OUTLINE Randomized study Following treatment on Regimen A patients with stable or objective response are randomized to Arms I and II Regimen A 2-Drug Combination Chemotherapy Paclitaxel Bristol-Myers Taxol NSC-125973 Cisplatin CDDP NSC-119875 Arm I Surgery followed by 2-Drug Combination Chemotherapy Laparotomy with resection of residual disease followed by TaxolCDDP Arm II 2-Drug Combination Chemotherapy Taxol CDDP
PROJECTED ACCRUAL Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients
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 |
|---|---|---|---|
| GOG-152 | None | None | None |