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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedNatural history/Epidemiology, TreatmentActive18 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 have squamous cell carcinoma with a depth invasion > 1 mm

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

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

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

Patients must sign informed consent

Exclusion Criteria:

Inoperable tumors with diameter > 4 cm

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

Patients with multifocal tumors

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 / 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

University of Arizona Cancer Center at Saint Joseph's

John Hall Farley
Ph: 877-602-4111

John Hall Farley
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

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

Illinois
Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
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

Missouri
Springfield

CoxHealth South Hospital

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New Jersey
Morristown

Morristown Medical Center

Daniel Henry Tobias
Ph: 973-971-5900

Daniel Henry Tobias
Principal Investigator

New York
Buffalo

Roswell Park Cancer Institute

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

Shamshad Ali
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

Rhode Island
Providence

Women and Infants Hospital

Richard G. Moore
Ph: 401-274-1122

Richard G. Moore
Principal Investigator

South Carolina
Greenville

Greenville Health System Cancer Institute-Faris

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Texas
Dallas

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

Houston

M D Anderson Cancer Center

Charles F. Levenback
Ph: 713-792-3245

Charles F. Levenback
Principal Investigator

Virginia
Roanoke

Carilion Clinic Gynecological Oncology

Janet L. Osborne
Ph: 540-985-8510

Janet L. Osborne
Principal Investigator

Canada

Ontario
Toronto

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Allan L. Covens
Ph: 416-480-5000

Allan L. Covens
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier 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.