Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003214
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
1999-11-01
Brief Title:
Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma Phase III
Status:
COMPLETED
Status Verified Date:
2019-05
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 Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug
PURPOSE Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery
PURPOSE Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery
Detailed Description:
OBJECTIVES I Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage IIIIV ovarian cancer
OUTLINE This is a randomized study Patients are stratified according to size of tumor after debulking surgery stage and Swiss Group for Clinical Cancer Research center where treatment is received Within 14 days after patients undergo debulking surgery they are randomized to one of two treatment arms Arm I Patients randomized to this arm receive one of six treatment regimens Regimen A - cisplatincyclophosphamide Regimen B - cisplatincyclophosphamidedoxorubicin Regimen C - carboplatin Regimen D - carboplatincyclophosphamide Regimen E - cisplatinpaclitaxel Regimen F - carboplatinpaclitaxel Arm II Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery If no valid assay result is obtained patients receive carboplatincyclophosphamide Treatment is repeated every 3-4 weeks for a total of 6 courses Up to 4 more courses may be administered if a partial response is demonstrated Patients are followed every 3 months for the first 2 years and every 6 months thereafter
PROJECTED ACCRUAL Approximately 300 patients will be accrued for this study over 6 years
OUTLINE This is a randomized study Patients are stratified according to size of tumor after debulking surgery stage and Swiss Group for Clinical Cancer Research center where treatment is received Within 14 days after patients undergo debulking surgery they are randomized to one of two treatment arms Arm I Patients randomized to this arm receive one of six treatment regimens Regimen A - cisplatincyclophosphamide Regimen B - cisplatincyclophosphamidedoxorubicin Regimen C - carboplatin Regimen D - carboplatincyclophosphamide Regimen E - cisplatinpaclitaxel Regimen F - carboplatinpaclitaxel Arm II Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery If no valid assay result is obtained patients receive carboplatincyclophosphamide Treatment is repeated every 3-4 weeks for a total of 6 courses Up to 4 more courses may be administered if a partial response is demonstrated Patients are followed every 3 months for the first 2 years and every 6 months thereafter
PROJECTED ACCRUAL Approximately 300 patients will be accrued for this study over 6 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 |
|---|---|---|---|
| EU-97036 | None | None | None |
| SWS-SAKK-4594 | None | None | None |