Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
Primary Purpose
Vulvar Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
regional lymph node dissection
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Cancer focused on measuring stage III vulvar cancer, squamous cell carcinoma of the vulva
Eligibility Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Recurrence rate
Survival rate
Subjective status on GOG performance scale
Time to recurrence
Survival time
Morbidity of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00898352
First Posted
May 8, 2009
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00898352
Brief Title
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
Official Title
Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
November 1990 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
stage III vulvar cancer, squamous cell carcinoma of the vulva
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
regional lymph node dissection
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Recurrence rate
Title
Survival rate
Title
Subjective status on GOG performance scale
Title
Time to recurrence
Title
Survival time
Title
Morbidity of treatment
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George C. Lewis, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
19701032
Citation
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):537-546. doi: 10.1097/AOG.0b013e3181b12f99.
Results Reference
result
PubMed Identifier
3785783
Citation
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.
Results Reference
result
Learn more about this trial
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
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