Observation in Patients with Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedNatural history/Epidemiology, Treatment18 and overGOG-0270
NCI-2012-00100, CDR0000721346, NCT01500512

Trial Description

Summary

This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.

Further Study Information

PRIMARY OBJECTIVES:

I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure.

OUTLINE:

Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.

Eligibility Criteria

Inclusion Criteria:

Patients must sign informed consent

Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes

Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible

Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes

Patients must have squamous cell carcinoma with a depth invasion > 1 mm

Exclusion Criteria:

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

Inoperable tumors with diameter > 4 cm

Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial

Patients with multifocal tumors

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Brian M. Slomovitz, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

Saint Joseph's Hospital and Medical Center

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

Bradley James Monk
Principal Investigator

California
Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center

Krishnansu Sujata Tewari
Ph: 714-456-6191
Email: awallick@uci.edu

Krishnansu Sujata Tewari
Principal Investigator

Florida
Miami

Jackson Memorial Hospital-Holtz Children's Hospital

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

Brian M. Slomovitz
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

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

Brian M. Slomovitz
Principal Investigator

Kansas
Kansas City

University of Kansas Cancer Center

Gary Alan Johnson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Gary Alan Johnson
Principal Investigator

Massachusetts
Springfield

Baystate Medical Center

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

Tashanna Keisha Nicole Myers
Principal Investigator

Minnesota
Minneapolis

University of Minnesota Medical Center-Fairview

Peter Alexander Argenta
Ph: 612-624-2620

Peter Alexander Argenta
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New York
Buffalo

Roswell Park Cancer Institute

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

Shamshad Ali
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

North Carolina
Chapel Hill

University of North Carolina at Chapel Hill

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

Linda Van Le
Principal Investigator

Ohio
Columbus

Ohio State University Comprehensive Cancer Center

David M. O'Malley
Ph: 800-293-5066
Email: Jamesline@osumc.edu

David M. O'Malley
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

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

Robert S. Mannel
Principal Investigator

Pennsylvania
Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Marilyn Huang
Ph: 412-647-2811

Marilyn Huang
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Richard G. Moore
Ph: 401-274-1122

Richard G. Moore
Principal Investigator

Texas
Houston

M D Anderson Cancer Center

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

Charles F. Levenback
Principal Investigator

Virginia
Roanoke

Carilion Clinic Gynecological Oncology

Janet L. Osborne
Ph: 540-985-8510

Janet L. Osborne
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01500512

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.