Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

This study has been completed.
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: October 3, 2003
Last updated: January 14, 2014
Last verified: July 2008

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: Masking: Open Label
Official Title: Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Enrollment: 102
Study Start Date: July 2004
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00070317

  Show 36 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Study Chair: Charles Levenback, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group Identifier: NCT00070317     History of Changes
Other Study ID Numbers: CDR0000331918, GOG-0206
Study First Received: October 3, 2003
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage I cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Methylene Blue
Technetium Tc 99m Sulfur Colloid
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals processed this record on May 21, 2015