Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003325
Other study ID # GOG-0173
Secondary ID CDR0000066277NCI
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated May 27, 2015
Start date December 1999

Study information

Verified date May 2015
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.

PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.


Description:

OBJECTIVES:

- Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.

- Determine the location of the sentinel node in these patients.

OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.

PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.


Recruitment information / eligibility

Status Completed
Enrollment 515
Est. completion date
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg

- Tumor size must be 2-6 cm

- No recurrent disease

- Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed

- No tumor extending into the urethra, anus, vagina, rectum, or bladder

- No grossly suspicious or inflamed groin nodes on physical exam

- No grossly infected primary tumors

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-3

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No other invasive malignancy within the past 5 years except non-melanomatous skin cancer

- No known hypersensitivity to phenylethane compounds

PRIOR CONCURRENT THERAPY:

- No prior cancer therapy that contraindicates therapy in this study

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

- No prior groin dissection

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Sentinel lymph node mapping
Sentinel lymph node mapping

Locations

Country Name City State
United States Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States Hope A Women's Cancer Center Asheville North Carolina
United States Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore Maryland
United States Tufts-NEMC Cancer Center Boston Massachusetts
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Cleveland Clinic Cancer Center at Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Parkland Memorial Hospital Dallas Texas
United States Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas
United States UT Southwestern University Hospital - Zale Lipshy Dallas Texas
United States Elkhart General Hospital Elkhart Indiana
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Hinsdale Hematology Oncology Associates Hinsdale Illinois
United States M. D. Anderson Cancer Center at University of Texas Houston Texas
United States Gynecologic Oncology of Indiana Indianapolis Indiana
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States St. Vincent Indianapolis Hospital Indianapolis Indiana
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States Women's Cancer Center - Lake Mead Las Vegas Nevada
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach California
United States University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights Ohio
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Baptist Centers for Cancer Care Memphis Tennessee
United States Lake/University Ireland Cancer Center Mentor Ohio
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain Connecticut
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States UPMC Cancer Center at Magee-Womens Hospital Pittsburgh Pennsylvania
United States Maine Medical Center - Bramhall Campus Portland Maine
United States Carilion Gynecologic Oncology Associates Roanoke Virginia
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States LDS Hospital Salt Lake City Utah
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States St. John's Regional Health Center Springfield Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph St. Joseph Michigan
United States CCOP - Scott and White Hospital Temple Texas
United States Cancer Care Associates - Saint Francis Campus Tulsa Oklahoma
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Washington Cancer Institute at Washington Hospital Center Washington District of Columbia
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Levenback CF, Ali S, Coleman RL, Gold MA, Fowler JM, Judson PL, Bell MC, De Geest K, Spirtos NM, Potkul RK, Leitao MM Jr, Bakkum-Gamez JN, Rossi EC, Lentz SS, Burke JJ 2nd, Van Le L, Trimble CL. Lymphatic mapping and sentinel lymph node biopsy in women wi — View Citation

Levenback CF, Tian C, Coleman RL, et al.: Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5505, 2009.

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive value of negative sentinel lymph nodes in vulvar cancer patients at time of surgery No
See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT01986725 - The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence Phase 2
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT05372016 - Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05743517 - Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment) N/A
Recruiting NCT05914974 - Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting NCT05979610 - Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Active, not recruiting NCT04357873 - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Terminated NCT00669422 - ChemoFx® PRO - A Post-Market Data Collection Study N/A
Completed NCT03676101 - Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 1
Not yet recruiting NCT06039111 - Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma Phase 2
Recruiting NCT06127836 - Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer N/A
Completed NCT04952961 - Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study N/A
Completed NCT01806350 - Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors N/A
Completed NCT00019110 - Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Phase 1
Recruiting NCT04141449 - A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Phase 2