colorectal cancer
Conditions
Interventions
Patients take orally 35 mg/m2 of a nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride twice a day (70 mg/m2/day, day 1-5, 8-12, q4w).
Sponsors
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are required to fulfill the following criteria for eligibility. 1) Histologically confirmed adenocarcinoma of colon or rectum. 2) One or more target lesions confirmed by CT or other imaging within 28 days before the registration. 3) One or more previous drug treatments including fluoropyrimidine-based regimen. 4) The Eastern Cooperative Oncology Group Performance Status of 0-2. 5) Ingestible. 6) Estimated to survive for three months or more since registration. 7) Written informed consent. 8) Age 65-84. 9) Fulfill the following hematological and biochemical data obtained in the most recent blood test. WBC >= 3,000 /mm3, neutrophils >= 1,500 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dl, AST =< 100 IU/l, ALT =< 100 IU/l, and total bilirubin =< 2.0 g/dl. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test. 10) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), time to treatment failure (TTF), overall response rate (ORR), toxicities, associations between efficacy/toxicity and screening score for comprehensive geriatric assessment, and associations between efficacy/toxicity and serum concentrations of trifluridine. | — |
Countries
Japan
Contacts
Public ContactHideki Shimodaira
Tohoku Clinical Oncology Research and Education Society (T-CORE) Administration Office
Outcome results
None listed