Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer
N/A
N/A
Female
Cervical Cancer
Trial Information
Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer
OBJECTIVES:
- Determine the sensitivity of the sentinel lymph node in the determination of lymph node
metastases, using preoperative or 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.
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Principal Investigator
Charles Levenback, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000331918
NCT ID:
NCT00070317
Start Date:
July 2004
Completion Date:
Related Keywords:
- Cervical Cancer
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- cervical squamous cell carcinoma
- stage I cervical cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
| Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
| Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| Gynecologic Oncology of West Michigan | Grand Rapids, Michigan 49546 |
