Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
|ClinicalTrials.gov Identifier: NCT00898352|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 27, 2013
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
|Condition or disease||Intervention/treatment||Phase|
|Vulvar Cancer||Procedure: regional lymph node dissection Radiation: radiation therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes|
|Primary Completion Date :||November 1990|
- Recurrence rate
- Survival rate
- Subjective status on GOG performance scale
- Time to recurrence
- Survival time
- Morbidity of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898352
|Study Chair:||George C. Lewis, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|