Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 [ 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.


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

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 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  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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female processed this record on October 21, 2016