Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/Epidemiology, TreatmentActive18 and overNCI, OtherGOG-0270
NCI-2012-00100, CDR0000721346, U10CA027469, NCT01500512

Trial Description

Summary

This observational trial studies how well surgery to remove the tumor and lymph nodes, and/or radiation therapy work in treating patients with early-stage vulvar cancer. Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery and/or radiation therapy are in treating vulvar cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To investigate the safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy in early-stage vulvar cancer patients with a sentinel node metastasis ≤ 2 mm.

II. To evaluate the short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo) radiotherapy.

III. To further establish the safety of omitting complete inguinofemoral lymphadenectomy in patients with a negative sentinel node.

IV. To explore the efficacy, safety, and short- and long-term morbidity of inguinofemoral lymphadenectomy and radiotherapy in patients with sentinel node metastasis > 2 mm. (exploratory)

OUTLINE: This is a multicenter study.

Patients undergo planned radical vulvectomy and sentinel lymph node dissection. Patients without lymph node involvement undergo observation. Patients with minimal lymph node involvement undergo radiotherapy. Patients with significant lymph node involvement undergo inguinofemoral lymphadenectomy and radiotherapy with or without chemotherapy according to institutional guidelines.

After completion of study treatment, patients are followed up every 2 months for 2 years. Follow-up includes interview, gynecological examination, and palpation of the groins.

Eligibility Criteria

Inclusion Criteria:

  • Patients with squamous cell carcinoma, depth of invasion > 1 mm
  • Patients with T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), tumors < 4 cm, and/or not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
  • Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
  • Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes
  • No inoperable tumors and tumors with diameter > 4 cm
  • No patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm)/suspicious groin nodes, and with cytologically proven inguinofemoral lymph node metastases
  • No patients with multifocal tumors
  • No concurrent intensity-modulated radiation therapy
  • Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

  • National Cancer Institute
Brian Slomovitz, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

St. Joseph's Hospital and Medical Center

Bradley J. Monk
Ph: 602-406-7730
Email: bradley.monk@chw.edu

Florida
Miami

Jackson Memorial Hospital

Brian M Slomovitz
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

University of Miami Sylvester Comprehensive Cancer Center - Miami

Brian M Slomovitz
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Kansas
Kansas City

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Julia A. Chapman
Ph: 913-588-4709

Massachusetts
Springfield

Baystate Medical Center

Tashanna K Myers
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Minnesota
Minneapolis

Masonic Cancer Center at University of Minnesota

Peter A Argenta
Ph: 612-624-2620

Nevada
Las Vegas

Women's Cancer Center - La Canada

Nick M. Spirtos
Ph: 702-851-4672

New Jersey
Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Brian M Slomovitz
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Summit

Overlook Hospital

Brian M Slomovitz
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

New York
Buffalo

Roswell Park Cancer Institute

Shamshad Ali
Ph: 716-845-5702
Email: ali@gogstats.org

New York

Memorial Sloan-Kettering Cancer Center

Mario M Leitao
Ph: 212-639-7202

North Carolina
Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Linda Van Le
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Robert S. Mannel
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Rhode Island
Providence

Women and Infants Hospital of Rhode Island

Richard G Moore
Ph: 401-274-1122

Texas
Houston

M. D. Anderson Cancer Center at University of Texas

Charles Levenback
Ph: 713-745-2563
Email: clevenba@mdanderson.org

Virginia
Roanoke

Carilion Clinic Gynecological Oncology

Janet L. Osborne
Ph: 540-985-8510

Canada

Ontario
Toronto

Odette Cancer Centre at Sunnybrook

Allan Covens
Ph: 416-480-5000

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01500512
ClinicalTrials.gov processed this data on May 07, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.