Analysis of predictive biomarker and analysis of correlations between toxicities and SNPs that can be related to pharmacokinetics, in trifluridine/tipiracil hydrochloride therapy for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000021742
- Lead Sponsor
- Tohoku Clinical Oncology Research and Education Society (T-CORE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
Patients who fulfill the following criteria for exclusion are excluded. 1) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 2) Active infection and inflammation (the body temperature with >= 38.0 degree of celsius). 3) Active hepatitis. 4) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, and uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 5) Chronic diarrhea (>= 4 times a day, or watery). 6) Active gastrointestinal bleeding. 7) Effusion that requires drainage. 8) Thoracotomy, laparotomy, or laparoscopic surgery within 28 days before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Tissue biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from trifluridine/tipiracil hydrochloride therapy 2. Serum biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from trifluridine/tipiracil hydrochloride therapy 3. SNPs that correlate with toxicities from trifluridine/tipiracil hydrochloride therapy
- Secondary Outcome Measures
Name Time Method