Colorectal Cancer
Conditions
Interventions
The patients were additionally taken 7.5ml blood samples on the day1, 8, 15 and 29 of the protocol regimen.
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients providing the written informed consent. 2) Patients are >=70 years of age (age at the time of enrollment) 3) Patients with colorectal cancer (excluding appendiceal cancer) pathologically diagnosed. 4) Unresectable colorectal cancer and chemotherapy was not performed as pre-treatment (recurrent patients under adjuvant therapy and within 6 months after adjuvant therapy excluding adjuvant therapy for pathological stage II - III are ineligible) 5) Patients with any of the following: (1) Patients who the standard therapy is possible, but does not enforce the standard therapy by the consultation of investigator and patient (fit) (2) Patients who cannot be received the same standard treatment as a general young people, but can be received some kind of treatment (vulnerable). 6) Performance Status (ECOG) 0 or 1 7) Patients capable of treatment with oral medicine 8) Patients have measurable lesion according to RECIST version 1.1 criteria by trunk part contract-enhanced CT within 28 days before enrollment 9) Patients with sufficient organ function 10) He/she can accept contraception by an appropriate method from the study drug administration to 6 months after final administration. 11) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria i) WBC <=12,000/mm3 ii) Neutrophil >=1,500/mm3 iii) Platelet >=100,000/mm3 iv) Hemoglobin >=8.0g/dL v) Total bilirubin <=1.5mg/dL vi) AST, ALT <=100IU/L vii) Albumin >=2.5g/dL viii) Serum creatinine <=1.5mg/dL ix) Creatinine clearance >=60mL/min
Exclusion criteria
Exclusion criteria: 1) Serious drug-induced hypersensitivity (especially, platinum formulation, 5-FU, TFTD) 2) Patients received palliative operation (it is eligible at 28 days after the operation with the intestinal anastomosis, at 14 days after colostomy) 3) Patients with active infectious disorder 4) Patients with uncontrollable hypertension. 5) Patients with under treatment by continuous use of insulin or with complication of uncontrollable diabetes mellitus 6) Patients with cardiac disorder such as congestive heart failure, angina to need medication, transmural myocardial infarction definitely observed in ECG, clinically apparent valvular disease, symptomatic coronary disease, uncontrollable arrhythmia, anamnesis of myocardial infarction that developed within the past 12 months. 7) Patients with severe pulmonary disorder such as interstitial pneumonia, pulmonary fibrosis, severe emphysema. 8) Patients with mental disorder or with anamnesis of central nervous system disorder. 9) Patients who have the fresh bleeding from gastrointestinal tract needing a transfusion repeatedly. 10) Patients who are receiving anticoagulant. 11) Patients with watery stool (>=Grade2) 12) Active double cancer. Synchronous double cancer and metachronous double cancer within a disease-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers. 13) Male patients with hope of pregnancy of his partner. 14) Patients with cirrhosis or active hepatitis. 15) Any other patients who are regarded as unsuitable for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The association between the proportion of FTD positive cells and the response rate, overall survival or the frequency of the adverse effect of TFTD. | — |
Countries
Japan
Contacts
Public ContactKSCC Research Secretariat
Kyushu Study group of Clinical Cancer KSCC Research Secretariat
Outcome results
None listed