Status:
UNKNOWN
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
Lead Sponsor:
Saint John's Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: * To determine the accuracy and sensitivity of intraoperative lymph node mapping with isosulfan blue and sentinal node biopsy (SLN) in patients with colorectal cancer (CRC). * To compare ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00625625
Start Date
March 1 2004
Last Update
September 17 2013
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