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

Gynecologic Oncology Group (GOG)

Status: Terminated

Conditions: Cervical Adenosquamous Carcinoma; Cervical Adenocarcinoma; Cervical Squamous Cell Carcinoma; Stage I Cervical Cancer

Treatments: Procedure: Radionuclide Imaging; Procedure: Sentinel Lymph Node Biopsy; Drug: Methylene Blue; Procedure: Lymph Node Mapping; Drug: Isosulfan Blue; Radiation: Technetium Tc-99m Sulfur Colloid; Procedure: Therapeutic Conventional Surgery; Procedure: Lymphangiography

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00070317

U10CA027469 (U.S. NIH Grant/Contract)

GOG-0206 (Other Identifier)

NCI-2012-02559 (Registry Identifier)

CDR0000331918

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

• No known allergy to triphenylmethane compounds

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Diagnostic

Experimental group

Description:

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.

Treatment:

Procedure: Lymphangiography

Radiation: Technetium Tc-99m Sulfur Colloid

Drug: Isosulfan Blue

Procedure: Lymph Node Mapping

Procedure: Therapeutic Conventional Surgery

Drug: Methylene Blue

Procedure: Sentinel Lymph Node Biopsy

Procedure: Radionuclide Imaging