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

Genetic and Rare Diseases Information Center resources: Vulvar Cancer

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes 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	Sidney Kimmel Cancer Center at Thomas Jefferson University

More Information

Publications:

Kunos C, Simpkins F, Gibbons H, Tian C, Homesley H. Radiation therapy compared with pelvic node resection for node-positive vulvar cancer: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):537-46. doi: 10.1097/AOG.0b013e3181b12f99.

Homesley HD, Bundy BN, Sedlis A, Adcock L. Radiation therapy versus pelvic node resection for carcinoma of the vulva with positive groin nodes. Obstet Gynecol. 1986 Dec;68(6):733-40.


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

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	Neoplasms Vulvar Diseases Genital Diseases, Female

ClinicalTrials.gov processed this record on September 19, 2017

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