Trials / Completed
CompletedNCT00898352
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | regional lymph node dissection | |
| RADIATION | radiation therapy |
Timeline
- Primary completion
- 1990-11-01
- First posted
- 2009-05-12
- Last updated
- 2013-05-27
Source: ClinicalTrials.gov record NCT00898352. Inclusion in this directory is not an endorsement.