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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00625625
First received: February 27, 2008
Last updated: September 16, 2013
Last verified: February 2008
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


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

Sponsors and Collaborators
John Wayne Cancer Institute at Saint John's Health Center
Investigators
Investigator: Shamim Baker John Wayne Cancer Institute at Saint John's Health Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00625625     History of Changes
Other Study ID Numbers: CDR0000586464, JWCI-GULS-CRCSLN-0104
Study First Received: February 27, 2008
Last Updated: September 16, 2013
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014