Genetic Markers in Patients With Colorectal Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Colorectal Cancer

Treatments: Genetic: loss of heterozygosity analysis; Genetic: microsatellite instability analysis; Genetic: DNA stability analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00014079

NCCTG-934655

CDR0000065549 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse.

PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer.

Full description

OBJECTIVES:

• Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer (tumor microsatellite instability).
• Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5, 8, 17, and 18 (as the primary targets) and of chromosomes 1, 14, and 22 (as the secondary targets) in colorectal cancer.

OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2).

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue up to 708 specimens.

Enrollment: 675 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Must have had a resectable adenocarcinoma of the colon or rectum and must have participated in one of the following NCCTG randomized clinical trials:

  • 784852: No Treatment Control Versus Levamisole Versus Levamisole Plus Fluorouracil (5-FU)
  • 794604: No Treatment Control Versus 5-FU by Portal Vein Infusion
  • 794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU
  • 844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  • 864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy
  • 874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  • 894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer

• Tissue blocks from the primary colorectal cancer must have been received by the NCCTG operations office

Trial design

675 participants in 1 patient group

Group 1

Description:

DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Treatment:

Genetic: microsatellite instability analysis

Genetic: loss of heterozygosity analysis

Genetic: DNA stability analysis