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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.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00898352
First received: May 8, 2009
Last updated: May 24, 2013
Last verified: October 2009
History of Changes
  Purpose

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:

MedlinePlus related topics: Vulvar Cancer
U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Recurrence rate [ Designated as safety issue: No ]
  • Survival rate [ Designated as safety issue: No ]
  • Subjective status on GOG performance scale [ Designated as safety issue: No ]
  • Time to recurrence [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Morbidity of treatment [ Designated as safety issue: Yes ]
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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898352

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: George C. Lewis, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00898352     History of Changes
Other Study ID Numbers: CDR0000070950, GOG-37, GOG-7712
Study First Received: May 8, 2009
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on February 27, 2015