COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00898352
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 27, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief Summary:

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : November 1990

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer

Primary Outcome Measures :
  1. Recurrence rate
  2. Survival rate
  3. Subjective status on GOG performance scale
  4. Time to recurrence
  5. Survival time
  6. Morbidity of treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Information from the National Library of Medicine

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 identifier (NCT number): NCT00898352

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: George C. Lewis, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
Publications of Results:
Layout table for additonal information
Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group Identifier: NCT00898352    
Other Study ID Numbers: CDR0000070950
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: October 2009
Keywords provided by Gynecologic Oncology Group:
stage III vulvar cancer
squamous cell carcinoma of the vulva
Additional relevant MeSH terms:
Layout table for MeSH terms
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases