Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006096
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
2000-08-03
Brief Title:
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I Stage II or Stage III Cancer of the Vulva
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
Status:
TERMINATED
Status Verified Date:
2007-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I stage II or stage III cancer of the vulva
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I stage II or stage III cancer of the vulva
Detailed Description:
OBJECTIVES
Compare the recurrence-free interval and survival in patients with stage I II III or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to primary surgical resection yes vs no and node status N1 vs N2 Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks
Arm II Patients undergo radiotherapy as in arm I Patients also receive cisplatin IV over 1 hour on days 1 8 15 22 29 and 36
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 250 patients will be accrued for this study within 45 years
Compare the recurrence-free interval and survival in patients with stage I II III or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to primary surgical resection yes vs no and node status N1 vs N2 Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks
Arm II Patients undergo radiotherapy as in arm I Patients also receive cisplatin IV over 1 hour on days 1 8 15 22 29 and 36
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 250 patients will be accrued for this study within 45 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 |
|---|---|---|---|
| GOG-0185 | None | None | None |