Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
Procedure: regional lymph node dissection
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes|
- Recurrence rate [ Designated as safety issue: No ]
- Survival rate [ Designated as safety issue: No ]
- Subjective status on GOG performance scale [ Designated as safety issue: No ]
- Time to recurrence [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Morbidity of treatment [ Designated as safety issue: Yes ]
|Primary Completion Date:||November 1990 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898352
|Study Chair:||George C. Lewis, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|