Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068406
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2003-09-10
Brief Title:
Chemotherapy Radiation Therapy and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery
Detailed Description:
OBJECTIVES
I Determine the efficacy of radiotherapy and cisplatin in terms of achieving a complete clinical and pathological response in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy
II Determine the toxicity of this regimen followed by surgery in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1 Treatment repeats weekly for approximately 65 weeks a total of 32 fractions of radiotherapy in the absence of unacceptable toxicity
Six to eight weeks after the completion of chemoradiotherapy patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinalfemoral nodes if the groin nodes were initially unresectable Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Determine the efficacy of radiotherapy and cisplatin in terms of achieving a complete clinical and pathological response in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy
II Determine the toxicity of this regimen followed by surgery in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1 Treatment repeats weekly for approximately 65 weeks a total of 32 fractions of radiotherapy in the absence of unacceptable toxicity
Six to eight weeks after the completion of chemoradiotherapy patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinalfemoral nodes if the groin nodes were initially unresectable Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00582 | REGISTRY | None | None |
| CDR0000322259 | None | None | None |
| GOG-0205 | OTHER | None | None |
| GOG-0205 | OTHER | None | None |