Studying Lymph Nodes in Patients With Stage II Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00949312
First received: July 29, 2009
Last updated: August 14, 2009
Last verified: July 2009
  Purpose

RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.

PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.


Condition Intervention Phase
Colorectal Cancer
Genetic: DNA analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
Procedure: regional lymph node dissection
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Ultrastaging of Early Colon Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-free survival (time to local or distant recurrence after resection) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
  • Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.

OUTLINE: This is a multicenter study.

Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.

Patients are followed up periodically for 4 years after surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer by proctosigmoidoscopy, flexible endoscopy, or gastrografin/barium enema within the past 8 weeks
  • Must have ≥ 12 negative lymph nodes (N0) by standard pathological testing (i.e., hematoxylin and eosin staining of a single 4-μm nodal section of each paraffin-embedded lymph node)
  • No evidence of distant metastases by CT scan of the abdomen and pelvis and chest x-ray or CT scan of the chest within the past 8 weeks

    • Preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be allowed pending intraoperative exploration

PATIENT CHARACTERISTICS:

  • ECOG/ZUBROD performance status 0-2
  • Life expectancy > 5 years (not including the disease and/or diagnosis of colon cancer)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Willing to be followed clinically or by phone, e-mail, or mail correspondence
  • No history of any of the following:

    • Crohn's disease
    • Chronic ulcerative colitis
    • Familial polyposis
  • No condition requiring emergency surgery (within 2 hours of presentation) to prevent a life-threatening situation or death, including any of the following:

    • Perforated colon
    • Metabolically significant complete bowel obstruction

      • Early or partial bowel obstruction not requiring emergency surgery allowed
    • Massive gastrointestinal bleeding

      • Occult bleeding not requiring emergency surgery allowed
  • No other malignancy within the past 3 years except for completely resected cervical cancer, skin cancer, or in-situ cancer

PRIOR CONCURRENT THERAPY:

  • No prior complete polypectomy by endoscopy
  • No concurrent systemic chemotherapy
  • No concurrent participation in another research protocol, except during study follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949312

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a    888-798-0719      
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center    202-782-7840      
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Anton J. Bilchik, MD, PhD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Anton J. Bilchik, Jonsson Comprehensive Cancer Center at UCLA
ClinicalTrials.gov Identifier: NCT00949312     History of Changes
Other Study ID Numbers: CDR0000649763, UCLA-0809064, BILA-UECC-0107, IRB# 08-09-064-02
Study First Received: July 29, 2009
Last Updated: August 14, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
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 July 31, 2014