Untreated metastatic colorectal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium)
INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium
Therapeutic category code :
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed colorectal adenocarcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy - Age:20-79 years - ECOG Performance status:0-1 - Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) - No prior chemotherapy or radiotherapy(Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment) - Adequate oral intake - Adequate function of major organs - Life expectancy of at least 3 months - Voluntary written informed consent
Exclusion criteria
Exclusion criteria: - Serious drug hypersensitivity or a history of drug allergy - Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. - Active infections (e.g., patients with pyrexia of 38 degrees C or higher) - Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension) - Remarkable electrocardiographic abnormality, or cardiac disease (cardiac failure, cardiac infarction, and angina pectoris) - Gastrointestinal ulcer or bleeding - Peripheral sensory neuropathy - Serious diarrhea - Ascites or pleural effusion requiring treatment - Brain metastasis - History of gastrointestinal perforation within 6 months - History of thrombo-embolism, cerebral infarction, pulmonary infarction, interstitial pneumonia - Major surgical procedure within 4 weeks - History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding - Concurrent treatment with anti-coagulation drug - Active double cancer - Prior treatment with oxaliplatin as adjuvant chemotherapy - Continuous treatment with steroids - Judged ineligible for participation in the study by the investigator - Case who has primary lesion with severe stenosis that endoscope doesn't pass(e.g., primary resection or colostomy) - Case who has peritoneum metastasis that can be confirmed by image
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS) Response rate(RR) Disease control rate(DCR) Time to progression(TTP) Time to treatment failure(TTF) Resection rate(R0-R) Safety | — |
Outcome results
None listed