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Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer


N/A
N/A
N/A
Not Enrolling
Female
Cervical Cancer

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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 InstituteBuffalo, New York  14263
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546