UMIN ID: UMIN000001148
Registered date:07/05/2008
Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.
Basic Information
| Recruitment status | Suspended |
|---|---|
| Health condition(s) or Problem(s) studied | Gastric Cancer |
| Date of first enrollment | 2008/05/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | UFT:300-600 mg/body/day Day 1-5 One course takes 7 days. In total of one year administration of UFT and TS-1 |
Outcome(s)
| Primary Outcome | Feasibility |
|---|---|
| Secondary Outcome | Safety of UFT Relapse-Free Survival Overall Survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | administration contraindication of UFT Severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) Severe watery diarrhea. HIV+ Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial. |
Related Information
| Primary Sponsor | Division of Gastrointestinal Surgery, Kobe University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takashi Kamigaki |
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Japan |
| Telephone | 078-382-5925 |
| Affiliation | Kobe University Graduate School of Medicine Division of Gastrointestinal Surgery |
| scientific contact | |
| Name | Takashi Kamigaki |
| Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Japan |
| Telephone | 078-382-5925 |
| Affiliation | Kobe University Graduate School of Medicine Division of Gastrointestinal Surgery |