Studying Lymph Nodes in Patients With Stage II Colon Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by John Wayne Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Wayne Cancer Institute
ClinicalTrials.gov Identifier:
NCT00949312
First received: July 29, 2009
Last updated: October 10, 2014
Last verified: October 2014
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrastaging of Early Colon Cancer

Resource links provided by NLM:


Further study details as provided by John Wayne Cancer Institute:

Primary Outcome Measures:
  • Disease-free survival (time to local or distant recurrence after resection) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer


Secondary Outcome Measures:
  • Overall survival (time to death from colorectal cancer) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    The event to be used for DFS is time to death after resection of colon cancer


Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: IHC testing of Lymph Nodes 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

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

Inclusion Criteria: All of the following inclusion criteria must be met in order for the subject to be eligible.

  1. Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
  2. Subjects with CC must have a computerized tomography (CT; at a minimum - spiral (helical) CT with 5-mm contiguous reconstruction algorithms and adequate volume (based on site-specific protocols) of oral and intravenous contrast agents) of the abdomen and pelvis and a chest x-ray or CT of the chest per standard of care, within 8 weeks prior to enrollment to rule out distant metastases. Subjects with preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration.
  3. Greater than 18 years of age
  4. Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
  5. Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
  6. Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
  7. Subject must have clinical assessment conducted by phone unless patients follow up are part of the regular clinical visits.

Exclusion Criteria: Any of the following criteria will exclude the subject from the study.

  1. Subjects requiring emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death such as those with a perforated colon, metabolically significant complete bowel obstruction or massive GI bleeding will be excluded. Subjects who do not require emergent surgery, such as those with occult bleeding or early or partial bowel obstruction will be permitted to enter.
  2. Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
  3. Discovery of distant metastases intra-operatively.
  4. Subjects with history of another malignancy over the last three years (except for completely resected cervical, skin cancers or in-situ cancers - see Appendix B for a list of exempt cancers).
  5. Pregnant and/or lactating women. Potentially childbearing subjects (pre-menopausal women) should undergo a pregnancy test within 7 days prior to surgery and after signing consent. Subjects found to be pregnant will be ineligible and withdrawn from the study.
  6. Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
  7. Systemic chemotherapy for node negative colon cancer.
  8. Complete polypectomy by endoscopy
  9. Less than 12 lymph nodes
  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

Contacts
Contact: Anton J. Bilchik, MD, PhD, FACS (310) 449-5206 bilchika@JWCI.org

Locations
United States, California
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Lisa van Kreuningen, M.S.    310-582-7053    lvk@jwci.org   
Principal Investigator: Anton J. Bilchik, MD, PhD, FACS         
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
John Wayne Cancer Institute
Investigators
Principal Investigator: Anton J. Bilchik, MD, PhD, FACS John Wayne Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: John Wayne Cancer Institute
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: October 10, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by John Wayne Cancer Institute:
stage II colon cancer

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

ClinicalTrials.gov processed this record on October 21, 2014