Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-01

Study Completion Date

2017-03-31

Brief Summary

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RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.

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Detailed Description

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OBJECTIVES:

* Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
* Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.

OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.

Patients' enzyme expression levels are compared with their clinical data.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed stage III colon adenocarcinoma
* Curatively resected (R0)
* Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
* Provided written informed consent

Exclusion Criteria

* Synchronous or metachronous multiple cancers
* Contraindications for fluorouracil-based chemotherapy
* Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
* Ineligible patients according to the investigator's judgement

Eligible Sex

ALL

Accepts Healthy Volunteers

No