Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes
N/A
N/A
Female
Vulvar Cancer
Trial Information
Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Recurrence rate
Safety Issue:
No
Principal Investigator
George C. Lewis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kimmel Cancer Center (KCC)
Authority:
United States: Federal Government
Study ID:
CDR0000070950
NCT ID:
NCT00898352
Start Date:
Completion Date:
Related Keywords:
- Vulvar Cancer
- stage III vulvar cancer
- squamous cell carcinoma of the vulva
- Carcinoma, Squamous Cell
- Vulvar Neoplasms
Name | Location |
|---|
