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.

Condition	Treatment or Intervention
stage I rectal cancer stage I colon cancer stage III colon cancer stage III rectal cancer stage II colon cancer stage II rectal cancer	Drug: technetium Tc 99m sulfur colloid

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• See Disease Characteristics
• No prior colonic, aortic, or retroperitoneal surgery

--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

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States

Study chairs or principal investigators

Timothy J. Yeatman,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000067803; MCC-11785; NCI-G00-1780; MCC-IRB-5033
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005640
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08