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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

Brief Summary: 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. 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.

Detailed Summary:

OBJECTIVES:

I. 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.

II. 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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Sensitivity, defined as the proportion of patients who test as SN (+) among the patients who have LN metastases (LN+) [ Time Frame: At the time of surgery ]

The confidence interval of the sensitivity will be calculated by appropriate method.


Original Primary Outcome:

Current Secondary Outcome: Success rate of SN identification [ Time Frame: Up to 8 years ]

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: October 3, 2003
Date Started: June 2004
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015