Stage IIIb colorectal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin)
INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium , ox
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A histopathologically confirmed diagnosis of stage IIIb adenocarcinoma of the colon (from the cecum to the sigmoid [C to S]), rectosigmoid (RS) cancer, or cancer of the rectum above the peritoneal reflection (Ra) (excluding cancer of the appendix). 2) Curability A surgery has been performed. 3) An age of 20 years to 80 years at enrollment. 4) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5) No treatment other than surgery for the target disease. 6) Oral intake is possible. 7) Adequate major organ function on laboratory testing within 14 days before enrollment. (Testing on the same day of the week 2 weeks before enrollment is permitted.) 8) Treatment can be started within 8 weeks after surgery. 9) Written informed consent has been obtained directly from the patient.
Exclusion criteria
Exclusion criteria: 1) The inferior tumor margin involves the peritoneal reflection. 2) Active multiple cancer with a disease-free interval of less than 5 years. (Cured basal cell carcinoma or cervical cancer, or gastric cancer, esophageal cancer, or colorectal cancer invading the muscularis propria (pM) that was cured by endoscopic mucosal resection are possible.) 3) Serious postoperative complications (e.g., serious postoperative infections not cured by the time of enrollment, suture failure, and gastrointestinal bleeding). 4) Any of the following concurrent diseases a)Poorly controlled diabetes mellitus b)Poorly controlled hypertension c)Liver cirrhosis or liver failure d)Renal failure e)Interstitial pneumonia, pulmonary fibrosis, or severe emphysema f)Active infectious disease g)Heart failure, myocardial infarction, angina pectoris, or an markedly abnormal electrocardiogram within 6 months before enrollment 5) Neurologic (sensory) disorders 6) Serious diarrhoea 7) A history of serious drug sensitivity 8) Current treatment with flucytosine 9) Women who are pregnant or possibly pregnant, or men who want their partners to bear children 10) Difficulty to participate in clinical studies because of psychological diseases or symptoms 11) Registration in the study is considered inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Disease-free survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Relapse-free survival(RFS), Overall survival(OS), Safety | — |
Countries
Japan
Outcome results
None listed