Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.

PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients with colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Wayne Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal cancer as detected by proctosigmoidoscopy, flexible endoscopy, or gastrografin/barium enema

• No evidence of distant metastases by CT scan of the abdomen and pelvis AND chest x-ray or CT scan of the chest performed within 6 weeks prior to enrollment

• Preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration

• No discovery of distant metastases intra-operatively

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) or Zubrod PS equal to 2

• Life expectancy > 5 years not including the disease/diagnosis of colorectal cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No requirement for emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death including:

• Perforated colon

• Metabolically significant complete bowel obstruction

• Massive GI bleeding

• Occult bleeding or early or partial bowel obstruction not requiring emergent surgery allowed

• No history of Crohn disease, chronic ulcerative colitis, or familial polyposis

• No other malignancy within the past 3 years except for completely resected cervical cancer, skin cancer, or in situ cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• See Patient Characteristics

• No concurrent participation in another research protocol

• Participation during follow up allowed