Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
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|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|
|Actual Primary Completion Date :||November 1990|
- Recurrence rate
- Survival rate
- Subjective status on GOG performance scale
- Time to recurrence
- Survival time
- Morbidity of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|