Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: Biopsy of Sentinel Lymph Nodes; Procedure: Gamma Probe; Radiation: Technetium Tc 99m Sulfur Colloid; Procedure: Preoperative Endoscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005640

NCI-G00-1780 (Other Identifier)

MCC-11785

Details and patient eligibility

About

RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the ability to detect the extent of colorectal cancer.

PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.

Full description

OBJECTIVES: I. Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. II. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. III. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

OUTLINE: Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor. Patients are followed postoperatively, every 4-6 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Preoperative diagnosis of stage I, II, or III colorectal cancer No more than 90 days since diagnosis No tumor involving adjacent structures (T4 lesion) No clinical or radiological evidence of stage IV disease No total excision of primary tumor at diagnosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No severe decompensated liver disease, including cirrhosis Renal: Not specified Other: No known primary or secondary immunodeficiencies No other medical conditions or evidence of infection that would preclude study Not pregnant Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior colonic, aortic, or retroperitoneal surgery

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Mapping and Biopsy

Experimental group

Description:

Lymph node mapping and sentinel lymph node biopsy. Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor.

Treatment:

Procedure: Biopsy of Sentinel Lymph Nodes

Procedure: Preoperative Endoscopy

Procedure: Gamma Probe

Radiation: Technetium Tc 99m Sulfur Colloid