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

1. 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.
2. 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

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

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