Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
NCT ID: NCT00898352
Last Updated: 2013-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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PURPOSE: Patient abstract not available
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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regional lymph node dissection
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Gynecologic Oncology Group
Principal Investigators
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George C. Lewis, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
References
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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.
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.
Other Identifiers
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GOG-37
Identifier Type: -
Identifier Source: secondary_id
GOG-7712
Identifier Type: -
Identifier Source: secondary_id
CDR0000070950
Identifier Type: -
Identifier Source: org_study_id
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