Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00918827|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : June 2, 2017
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.
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||2128 participants|
|Official Title:||Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)|
|Study Start Date :||April 1, 2009|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
- Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival [ Time Frame: 5 years after the end of registration ]
- Relationship between expression levels of enzymes and adverse effects [ Time Frame: 5 years after the end of registration ]
- Disease-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ]
- Relapse-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918827
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Principal Investigator:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|