Skip to content

Gene Testing in Patients With Colon Cancer

Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00003571
Enrollment
300
Registered
2003-07-15
Start date
1998-08-31
Completion date
2006-01-31
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage III colon cancer, adenocarcinoma of the colon

Brief summary

RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer. PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

Detailed description

OBJECTIVES: * Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896. * Determine the prognostic and predictive values for response to this therapy in these patients.

Interventions

GENETICmutation analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896 * Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor * Surgical specimen blocks available, including tumor tissue and normal tissue

Design outcomes

Primary

MeasureTime frame
disease free survivalUp to 10 years

Secondary

MeasureTime frame
overall survivalUp to 10 years
tumor replication error statusUp to 10 years
determine the prognostic and predictive values for response to this therapyUp to 10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026