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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070317 |
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 | Intervention |
|---|---|
|
Cervical Cancer |
Drug: isosulfan blue Drug: methylene blue Procedure: conventional surgery Procedure: laparoscopic surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label |
| Official Title: | Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer |
| Estimated Enrollment: | 590 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then 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: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Gynecologic Oncology of West Michigan | |
| Grand Rapids, Michigan, United States, 49546 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07902 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| Cleveland Clinic Cancer Center at Fairview Hospital | |
| Cleveland, Ohio, United States, 44111 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Hillcrest Cancer Center at Hillcrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| United States, Oklahoma | |
| Cancer Care Associates - Midtown Tulsa | |
| Tulsa, Oklahoma, United States, 74104 | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84103 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Wisconsin | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Canada, Quebec | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Royal Victoria Hospital - Montreal | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| St. Mary's Hospital Center | |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Spain | |
| Centro Oncologico M.D. Anderson International Espana | |
| Madrid, Spain, 28033 | |
| Study Chair: | Charles Levenback, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000331918, GOG-0206 |
| Study First Received: | October 3, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070317 History of Changes |
| Health Authority: | United States: Federal Government |
|
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage I cervical cancer |
|
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Methylene Blue |
