Clinical trial NCT00918827: Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon
stage III colon cancer
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Tokyo Medical and Dental University
First posted: 2009-06-11
Enrollment: 2128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically confirmed stage III colon adenocarcinoma patients who are given treatment with fluorouracil-based post-opeartive adjuvant chemotherapy

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: \<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

Primary outcomes:
measure: Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
timeFrame: 5 years after the end of registration
measure: Relationship between expression levels of enzymes and adverse effects
timeFrame: 5 years after the end of registration
measure: Disease-free survival
timeFrame: Until the day on which an event reveals during the 5 year observational period
measure: Relapse-free survival
timeFrame: Until the day on which an event reveals during the 5 year observational period
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
Study officials:
affiliation: Tokyo Medical and Dental University
name: Kenichi Sugihara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishiguro M, Kotake K, Nishimura G, Tomita N, Ichikawa W, Takahashi K, Watanabe T, Furuhata T, Kondo K, Mori M, Kakeji Y, Kanazawa A, Kobayashi M, Okajima M, Hyodo I, Miyakoda K, Sugihara K. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. BMC Cancer. 2013 Mar 25;13:149. doi: 10.1186/1471-2407-13-149.