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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 SlomovitzPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Phoenix
 GOG of Arizona, PC
 Brian M Slomovitz Ph: 973-971-5900
  Email: brian.slomovitz@atlantichealth.org
 St. Joseph's Hospital and Medical Center
 Bradley J. Monk Ph: 602-406-7730
  Email: bradley.monk@chw.edu
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
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
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
Pennsylvania
  Pittsburgh
 UPMC Cancer Centers
 Marilyn Huang Ph: 412-647-2811
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Richard G Moore Ph: 401-274-1122
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Charles Levenback Ph: 713-745-2563
  Email: clevenba@mdanderson.org
Canada
Ontario
  Toronto
 Odette Cancer Centre at Sunnybrook
 Allan Covens Ph: 416-480-5000

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01500512
ClinicalTrials.gov processed this data on August 12, 2014

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.

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