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

September 16, 2013 updated by: Saint John's Cancer Institute

Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Disease-free survival
Sensitivity and accuracy of lymphatic mapping in colorectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint John's Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Shamim Baker, Saint John's Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Anticipated)

November 1, 2007

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000586464
  • JWCI-GULS-CRCSLN-0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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