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Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer

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Cervical Cancer

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Trial Information

Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer


- 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

Inclusion Criteria


- 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



- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No known allergy to triphenylmethane compounds


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- No prior pelvic irradiation


- 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:


Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Charles Levenback, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




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



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M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
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