Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002477
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Therapy With a Platinum-Containing Regimen eg CBDCA or CAP CTXDOXCDDP vs No Adjuvant Therapy in Patients With Fully Resected Early Stage Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 may kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine whether adjuvant chemotherapy with a platinum-containing regimen eg carboplatin or CAP cyclophosphamidedoxorubicincisplatin prolongs survival in patients with early stage ovarian cancer compared to those receiving no adjuvant treatment
OUTLINE Randomized study Patients are randomized to Arm I or II treatment should begin within 6 weeks of surgery Regimens listed in Arm I are recommended but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below Arm I Single-agent Chemotherapy or 3-Drug Combination Chemotherapy Carboplatin CBDCA NSC-241240 or CAP Cyclophosphamide CTX NSC-26271 Doxorubicin DOX NSC-123127 Cisplatin CDDP NSC-119875 Arm II Observation No adjuvant therapy
PROJECTED ACCRUAL A maximum of 2000 patients will be randomized
OUTLINE Randomized study Patients are randomized to Arm I or II treatment should begin within 6 weeks of surgery Regimens listed in Arm I are recommended but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below Arm I Single-agent Chemotherapy or 3-Drug Combination Chemotherapy Carboplatin CBDCA NSC-241240 or CAP Cyclophosphamide CTX NSC-26271 Doxorubicin DOX NSC-123127 Cisplatin CDDP NSC-119875 Arm II Observation No adjuvant therapy
PROJECTED ACCRUAL A maximum of 2000 patients will be randomized
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-91002 | None | None | None |
| MRC-ICON1 | None | None | None |