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Diagnostic Study of Lymphatic Mapping and Sentinel Node Identification in Patients With Stage IB1 Cervical Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Diagnostic, Treatment Closed Not specified NCI GOG-0206
NCT00070317

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.

Entry 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

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

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

Expected Enrollment

590

A total of 295-590 patients will be accrued for this study within 18-36 months.

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Charles Levenback, MD, Protocol chair
Ph: 713-745-2563; 800-392-1611
Email: clevenba@mdanderson.org

Registry Information

Official Title		Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer

Trial Start Date		2004-07-07

Trial Completion Date		2007-01-30 (estimated)

Registered in ClinicalTrials.gov		NCT00070317

Date Submitted to PDQ		2003-08-27

Information Last Verified		2008-07-23

NCI Grant/Contract Number		CA27469

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.