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Clinical Trial: Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
PURPOSE: This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer.
| Condition | Treatment or Intervention |
|---|---|
| cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage I cervical cancer | Drug: isosulfan blue Drug: methylene blue Drug: technetium Tc 99m sulfur colloid Procedure: conventional surgery Procedure: diagnostic test Procedure: lymphography Procedure: radionuclide imaging Procedure: sentinel node biopsy Procedure: surgery |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Cervical Cancer; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Diagnostic Study of Lymphatic Mapping and Sentinel Node Identification in Patients With Stage IB1 Cervical Cancer
Further Study Details:
OBJECTIVES:
- Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using combined preoperative and intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.
- Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.
OUTLINE: This is a multicenter study.
Prior to surgery, patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor and then undergo lymphoscintigraphy. Patients undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
PROJECTED ACCRUAL: A total of 295-590 patients will be accrued for this study within 18-36 months.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Stage IB1 disease (no greater than 4 cm)
- No unequivocal evidence of metastases
- Adequate surgical candidate
PATIENT CHARACTERISTICS: Age
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No known allergy to triphenylmethane compounds
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic irradiation
Surgery
- No prior retroperitoneal surgery
- More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy
- Prior cone biopsy allowed provided current disease is stage IB1
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Mack Barnes, MD 205-934-5077
Arizona
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Robert A. Burger, MD 714-456-7971 raburger@uci.edu
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1740, United States; Recruiting
Jonathan S. Berek, MD 310-206-5161
Women's Cancer Center - Los Gatos, Los Gatos, California, 95032, United States; Recruiting
Nick M. Spirtos, MD 408-866-3843 nspirtos@wccenter.com
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, 80010, United States; Recruiting
Francis J. Major, MD 303-388-4876 francis.major@usoncology.com
Connecticut
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8028, United States; Recruiting
Peter E. Schwartz, MD 203-785-4014 peter.schwartz@yale.edu
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
G. Scott Rose, MD 202-782-8515 scott.rose@na.amedd.army.mil
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
James V. Fiorica, MD 813-972-8478 fiorica@moffitt.usf.edu
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62794-9640, United States; Recruiting
L. Stewart Massad, MD 217-545-8882
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Rush University Medical Center, Chicago, Illinois, 60612-3824, United States; Recruiting
Howard T. Strassner, MD 312-942-6723
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Seiko Diane Yamada, MD 773-702-6722 sdyamada@babies.bsd.uchicago.edu
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Katherine Yvonne Look, MD 317-274-8987 klook@iupui.edu
Saint Joseph Regional Medical Center, South Bend, Indiana, 46617, United States; Recruiting
Michael W. Method, MD, MPH 574-237-8010 mmethod@mhopc.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1002, United States; Recruiting
Joel I. Sorosky, MD 319-356-2015 joel-sorosky@uiowa.edu
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Frederick Ueland, MD 606-257-1613 fredueland@yahoo.com
Massachusetts
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Kenneth L. Noller, MD 617-636-2382
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01605-2982, United States; Recruiting
Susan L. Zweizig, MD 508-334-1160 zweizig@ummhc.org
Michigan
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905-0001, United States; Recruiting
Harry J. Long, MD 507-284-4320 long.harry@mayo.edu
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Linda F. Carson, MD 612-626-3347 carso001@umn.edu
Mississippi
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, 39534-2576, United States; Recruiting
John Bomalaski, MD 228-377-6396 john.bomalaski@keesler.af.mil
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Sara Crowder, MD 573-882-1057 crowders@health.missouri.edu
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
David Gardner Mutch, MD 314-362-3181
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103-1489, United States; Recruiting
David P. Warshal, MD 856-342-2185 warshal-david@cooperhealth.edu
New York
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11790-7775, United States; Recruiting
Michael L. Pearl, MD 631-444-2774
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Carol L. Brown, MD 212-639-7659
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Andrew Menzin, MD 516-562-4438 amenzin@nshs.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Shashikant B. Lele, MD 716-845-5776 shashi.lele@roswellpark.org
North Carolina
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1065, United States; Recruiting
Brigitte E. Miller, MD 336-716-6673 bemiller@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Daniel L. Clarke-Pearson, MD 919-684-3765
Gynecologic Oncology Network, Greenville, North Carolina, 27858, United States; Recruiting
Howard David Homesley, MD 252-756-5388 hdh7173@aol.com
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7570, United States; Recruiting
Wesley C. Fowler, MD 919-966-1196 wfowler@med.unc.edu
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Jeffrey McCabe Fowler, MD 614-293-8737
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0520, United States; Recruiting
Nader Husseinzadeh, MD 513-558-8450 nallerhusseinzadeh@uc.edu
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44124, United States; Recruiting
Peter Graham Rose, MD 216-444-1712 rosep@ccf.org
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
Steven E. Waggoner, MD 216-844-5011
Oklahoma
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Robert S. Mannel, MD 405-271-8787 robert-mannel@ouhsc.edu
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Pennsylvania
Abington Memorial Hospital, Abington, Pennsylvania, 19001-3788, United States; Recruiting
Parviz Hanjani, MD 215-885-0220 phanjani@amh.org
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104-4283, United States; Recruiting
Mark A. Morgan, MD 215-662-6043
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Nava Siegelmann-Danieli, MD 570-271-6834 nsdanieli@geisinger.edu
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting
Michael A. Bookman, MD 215-728-2987 ma_bookman@fccc.edu
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Norman G. Rosenblum, MD, PhD 215-955-6200
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
George Olt, MD 717-531-8144
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, 15213-3180, United States; Recruiting
Joseph L. Kelley, MD 412-641-5418 jkelley@mail.magee.edu
South Carolina
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425-2233, United States; Recruiting
William T. Creasman, MD 843-792-4509 creasman@musc.edu
Tennessee
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, 37917, United States; Recruiting
Kenneth F. Cofer, MD 865-673-9250
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-2516, United States; Recruiting
Marta Ann Crispens, MD 615-322-2114 marta.crispens@vanderbilt.edu
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States; Recruiting
Charles Levenback, MD 713-745-2563 clevenba@mdanderson.org
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-9032, United States; Recruiting
David Scott Miller, MD 214-648-3026 david.miller@utsouthwestern.edu
University of Texas M.D. Anderson CCOP Research Base, Houston, Texas, 77030-4009, United States; Recruiting
W. Archie Bleyer, MD 713-792-8516 ableyer@mdanderson.org
University of Texas Medical Branch, Galveston, Texas, 77555-0587, United States; Recruiting
Edward V. Hannigan, MD 409-772-2368 ehanniga@utmb.edu
Vermont
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington, Vermont, 05401, United States; Recruiting
Cheung Wong, MD 802-847-5110 cheung.wong@vtmednet.org
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Willie Albert Andersen, MD 434-924-9333
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States; Recruiting
Benjamin E. Greer, MD 206-685-2463
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, 98405, United States; Recruiting
Roger B. Lee, MD 253-403-1029 rogerblee@aol.com
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Anthony Evans, MD, PhD 715-387-5161 evans.anthony@marshfieldclinic.org
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6188, United States; Recruiting
Ellen Hartenbach, MD 608-263-1209
Australia, New South Wales
Australia New Zealand Gynaecological Oncology Trials Group, Camperdown, New South Wales, 1450, Australia; Recruiting
Michael L. Friedlander, MD, PhD, FRACP 61-2-9562-1450 friedlanderM@sesahs.nsw.gov.au
Canada, Alberta
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, T2N 4N2, Canada; Recruiting
Gavin C.E. Stuart, MD 403-944-1721 gavinst@cancerboard.ab.ca
Japan
Kagoshima City Hospital, Kagoshima City, 892-8580, Japan; Recruiting
Masayuki Hatae, MD 81-99-224-2101
Norway
Norwegian Radium Hospital, Oslo, N-0310, Norway; Recruiting
Gunnar B. Kristensen, MD, PhD 47-22-93-40-00 gunnar.kristensen@klinmed.uio.no
United Kingdom, England
Queen Elizabeth Hospital at University of Birmingham, Birmingham, England, B15 2TH, United Kingdom; Recruiting
Christopher Poole, MD 44-121-472-1311
Study chairs or principal investigators
Charles Levenback, MD, Study Chair, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000331918; GOG-0206; NCT00070317
Record last reviewed: December 2004
Last Updated: April 5, 2005
Record first received: October 3, 2003
ClinicalTrials.gov Identifier: NCT00070317
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: April 5, 2005
Record first received: October 3, 2003
ClinicalTrials.gov Identifier: NCT00070317
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Methblue 65 (Drug Digest)
- Methylene Blue Oral (Drug Digest)
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