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Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group Identifier:
First received: May 8, 2009
Last updated: May 24, 2013
Last verified: October 2009

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Condition Intervention Phase
Vulvar Cancer
Procedure: regional lymph node dissection
Radiation: radiation therapy
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Recurrence rate
  • Survival rate
  • Subjective status on GOG performance scale
  • Time to recurrence
  • Survival time
  • Morbidity of treatment

Primary Completion Date: November 1990 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

  Contacts and Locations
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Please refer to this study by its identifier: NCT00898352

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: George C. Lewis, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
  More Information

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group Identifier: NCT00898352     History of Changes
Other Study ID Numbers: CDR0000070950
Study First Received: May 8, 2009
Last Updated: May 24, 2013

Keywords provided by Gynecologic Oncology Group:
stage III vulvar cancer
squamous cell carcinoma of the vulva

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female processed this record on May 25, 2017