Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
3 other identifiers
observational
2,128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedJune 2, 2017
June 1, 2017
8 years
June 9, 2009
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects
5 years after the end of registration
Disease-free survival
Until the day on which an event reveals during the 5 year observational period
Relapse-free survival
Until the day on which an event reveals during the 5 year observational period
Eligibility Criteria
Pathologically confirmed stage III colon adenocarcinoma patients who are given treatment with fluorouracil-based post-opeartive adjuvant chemotherapy
You may qualify if:
- Pathologically confirmed stage III colon adenocarcinoma
- Curatively resected (R0)
- Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
- Provided written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Medical and Dental University
Tokyo, 113-8519, Japan
Related Publications (1)
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.
PMID: 23530572DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenichi Sugihara, MD, PhD
Tokyo Medical and Dental University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 11, 2009
Study Start
April 1, 2009
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
June 2, 2017
Record last verified: 2017-06