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

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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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Recurrence rate


Condition

Vulvar Cancer

Intervention

regional lymph node dissection


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure




Primary Completion Date

November 1990

Eligibility Criteria

        DISEASE CHARACTERISTICS: See General Eligibility Criteria

        PATIENT CHARACTERISTICS: See General Eligibility Criteria
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

George C. Lewis, MD, , 



Administrative Informations


NCT ID

NCT00898352

Organization ID

CDR0000070950

Secondary IDs

GOG-37


Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

George C. Lewis, MD, Study Chair, Sidney Kimmel Cancer Center at Thomas Jefferson University


Verification Date

October 2009