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Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Primary Purpose

Vulvar Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sentinel lymph node mapping
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Cancer focused on measuring stage I vulvar cancer, stage II vulvar cancer, squamous cell carcinoma of the vulva

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Todd Cancer Institute at Long Beach Memorial Medical Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Helen and Harry Gray Cancer Center at Hartford Hospital
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
  • Washington Cancer Institute at Washington Hospital Center
  • Mayo Clinic - Jacksonville
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Hinsdale Hematology Oncology Associates
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Elkhart General Hospital
  • Indiana University Melvin and Bren Simon Cancer Center
  • Gynecologic Oncology of Indiana
  • St. Vincent Indianapolis Hospital
  • Howard Community Hospital
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • South Bend Clinic
  • Holden Comprehensive Cancer Center at University of Iowa
  • Maine Medical Center - Bramhall Campus
  • Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
  • Tufts-NEMC Cancer Center
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Masonic Cancer Center at University of Minnesota
  • Mayo Clinic Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Women's Cancer Center - Lake Mead
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • Memorial Sloan-Kettering Cancer Center
  • Hope A Women's Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Wake Forest University Comprehensive Cancer Center
  • Aultman Cancer Center at Aultman Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Case Comprehensive Cancer Center
  • Cleveland Clinic Cancer Center at Fairview Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Riverside Methodist Hospital Cancer Care
  • Mount Carmel Health - West Hospital
  • Hillcrest Cancer Center at Hillcrest Hospital
  • Lake/University Ireland Cancer Center
  • Oklahoma University Cancer Institute
  • Cancer Care Associates - Saint Francis Campus
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • Fox Chase Cancer Center - Philadelphia
  • UPMC Cancer Center at Magee-Womens Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • Avera Cancer Institute
  • Sanford Cancer Center at Sanford USD Medical Center
  • Baptist Centers for Cancer Care
  • Parkland Memorial Hospital
  • UT Southwestern University Hospital - Zale Lipshy
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • M. D. Anderson Cancer Center at University of Texas
  • CCOP - Scott and White Hospital
  • LDS Hospital
  • University of Virginia Cancer Center
  • Carilion Gynecologic Oncology Associates
  • Gundersen Lutheran Center for Cancer and Blood
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Waukesha Memorial Hospital Regional Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sentinenal lymph node mapping

Arm Description

Sentinenal lymph node mapping

Outcomes

Primary Outcome Measures

Predictive value of negative sentinel lymph nodes in vulvar cancer patients

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 27, 2015
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003325
Brief Title
Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
Official Title
Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
stage I vulvar cancer, stage II vulvar cancer, squamous cell carcinoma of the vulva

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sentinenal lymph node mapping
Arm Type
Other
Arm Description
Sentinenal lymph node mapping
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node mapping
Intervention Description
Sentinel lymph node mapping
Primary Outcome Measure Information:
Title
Predictive value of negative sentinel lymph nodes in vulvar cancer patients
Time Frame
at time of surgery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Levenback, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Todd Cancer Institute at Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Helen and Harry Gray Cancer Center at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Washington Cancer Institute at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Gynecologic Oncology of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Maine Medical Center - Bramhall Campus
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Tufts-NEMC Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Women's Cancer Center - Lake Mead
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Hope A Women's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Cancer Center at Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Hillcrest Cancer Center at Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Saint Francis Campus
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-1929
Country
United States
Facility Name
Rosenfeld Cancer Center at Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
UPMC Cancer Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Baptist Centers for Cancer Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern University Hospital - Zale Lipshy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion Gynecologic Oncology Associates
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22753905
Citation
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 with squamous cell carcinoma of the vulva: a gynecologic oncology group study. J Clin Oncol. 2012 Nov 1;30(31):3786-91. doi: 10.1200/JCO.2011.41.2528. Epub 2012 Jul 2.
Results Reference
result
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.
Results Reference
result

Learn more about this trial

Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

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