UMIN ID: UMIN000001094
Registered date:25/03/2008
Phase II study of caffeine combined chemotherapy in patients with high- grade bone and soft tissue tumor
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | High-grade bone and soft tissue tumor |
| Date of first enrollment | 2008/03/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Caffeine combined chemotherapy in which cisplatin over 4 hours followed by caffeine over 24 hours on days 1-3, to be repeaed every 3 weeks |
Outcome(s)
| Primary Outcome | The response rate of preoperative caffeine combined chemotherapy |
|---|---|
| Secondary Outcome | 2-year progression free survival, event-free survival, overall survival, incidence of adverse event |
Key inclusion & exclusion criteria
| Age minimum | 5years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.sever drug allergy 2.uncontrolled diabetes mellitus 3.uncontrolled hypertension 4.women during pregnancy |
Related Information
| Primary Sponsor | Group for "Caffeine combined chemotherapy in patients with high-grade bone and soft tissue tumor" |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshiharu Shirai |
| Address | 13-1 Takara-machi, Kanazawa 920-8640, Japan Japan |
| Telephone | 076-265-2374 |
| Affiliation | Coordinate Office Department of orthopaedic surgery, Graduate school of medical science, Kanazawa Univesity |
| scientific contact | |
| Name | Hiyoruki Tsuchiya |
| Address | 13-1 Takara-machi, Kanazawa 920-8640, Japan Japan |
| Telephone | |
| Affiliation | Kanazawa University Department of orthopaedic surgery, Graduate school of medical science |