UMIN ID: C000000285
Registered date:18/11/2005
Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | senior citizen's gastric cancer |
| Date of first enrollment | 2004/06/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TS1: 50 or 80 or 100 or 120 mg/body/day, orally 28 days, every 6 weeks |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | TTF, OS, Safety, Home treatment period, home treatment rate |
Key inclusion & exclusion criteria
| Age minimum | 75years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.History of severe drug allergic reaction 2.Severe Bone marrow suppression,renal and liver function disturbance 3.Concomitant therapy with another anticancer drug or flucytocine 4.Marked pleural effusion or ascites 5.Symptomatic brain metastasis 6.Intestinal fresh hemorrhage 7.Active secondary cancer 8.Accompanied serious diseases 9.Severe Ischemic heart disease or Arrhythmia which requires treatment 10.Watery diarrhea 11.Decision as ineligible by principal investigator |
Related Information
| Primary Sponsor | The Tokyo cooperative Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Tokyo cooperative Oncology Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | The Tokyo cooperative Oncology Group Secretariat |
| scientific contact | |
| Name | Minoru Kurihara |
| Address | 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan Japan |
| Telephone | |
| Affiliation | The Tokyo cooperative Oncology Group Director |