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

Sponsors and Collaborators:	John Wayne Cancer Institute at Saint John's Health Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00625625

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: isosulfan blue Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Procedure: diagnostic lymphadenectomy Procedure: therapeutic conventional surgery Procedure: therapeutic lymphadenectomy	Phase II

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Iso-sulfan blue

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Sensitivity and accuracy of lymphatic mapping in colorectal cancer [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	225
Study Start Date:	March 2004
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625625

Sponsors and Collaborators

John Wayne Cancer Institute at Saint John's Health Center

National Cancer Institute (NCI)

Investigators

Investigator:

Shamim Baker

John Wayne Cancer Institute at Saint John's Health Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000586464, JWCI-GULS-CRCSLN-0104
Study First Received:	February 27, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00625625 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I colon cancer
stage II colon cancer
stage III colon cancer

stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases

Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009