Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
Phase 3
Completed
- Conditions
- Vulvar Cancer
- Registration Number
- NCT00898352
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
- Detailed Description
OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes.
OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes.
PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence rate Survival rate Morbidity of treatment Subjective status on GOG performance scale Time to recurrence Survival time
- Secondary Outcome Measures
Name Time Method