Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
isosulfan blue
polymerase chain reaction
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
diagnostic lymphadenectomy
therapeutic conventional surgery
therapeutic lymphadenectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Sensitivity and accuracy of lymphatic mapping in colorectal cancer
Overall survival
Disease-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00625625
First Posted
February 27, 2008
Last Updated
September 16, 2013
Sponsor
Saint John's Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00625625
Brief Title
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
Official Title
Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
November 2007 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Saint John's Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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 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.
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 molecular and immunohistochemical methods for detection of micrometastases in the SLN and primary tumor and evaluate the clinical outcome.
To evaluate the clinicopathological utility of hematogenous micrometastases in predicting disease recurrence in CRC.
OUTLINE: Patients receive isosulfan blue subserosally around the primary tumor for sentinel lymph node (SLN) identification and SLN(s) are marked. Patients undergo a standard colon resection as planned to include the SLN(s) and regional lymph nodes.
Lymph nodes removed during surgery are analyzed within 30 days after surgery. Routine pathologic analysis (H&E) are performed on all lymph nodes (SLN and non-SLN) removed. Immunohistochemical (IHC) staining for cytokeratin antibodies AE-1/AE-3 or MAK-6 are performed on all lymph nodes negative by H&E. Multimarker PCR (MM PCR) are performed on all SLNs. Blood samples are collected at baseline and then periodically for 4 years for MM PCR to detect circulating tumor cells and standard tumor markers (e.g., CEA).
After surgery, patients are followed every 6 months for 4 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
isosulfan blue
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
diagnostic lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Procedure
Intervention Name(s)
therapeutic lymphadenectomy
Primary Outcome Measure Information:
Title
Sensitivity and accuracy of lymphatic mapping in colorectal cancer
Title
Overall survival
Title
Disease-free survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamim Baker
Organizational Affiliation
Saint John's Cancer Institute
12. IPD Sharing Statement
Learn more about this trial
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
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