Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsor:
Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator:
Tokyo Medical and Dental University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00918827
First received: June 9, 2009
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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 |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
Resource links provided by NLM:
Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Relationship between expression levels of enzymes and adverse effects [ Time Frame: 5 years after the end of registration ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918827
Locations
| Japan | |
| Tokyo Medical and Dental University | |
| Tokyo, Japan, 113-8519 | |
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Tokyo Medical and Dental University
Investigators
| Principal Investigator: | Kenichi Sugihara, MD, PhD | Tokyo Medical and Dental University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
| ClinicalTrials.gov Identifier: | NCT00918827 History of Changes |
| Other Study ID Numbers: | CDR0000642386, TMDU-TRICC0807, UMIN000002013 |
| Study First Received: | June 9, 2009 |
| Last Updated: | March 29, 2013 |
| Health Authority: | Japan: Institutional Review Board, Tokyo Medical and Dental University |
Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
|
adenocarcinoma of the colon stage III colon cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013