UMIN ID: C000000286
Registered date:18/11/2005
Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | 5-fluorouracil resistant advanced and recurrent Gastric Cancer |
| Date of first enrollment | 2005/06/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TXL 140mg/m2/week iv, day1.15 q 4weeks |
Outcome(s)
| Primary Outcome | Response Rate |
|---|---|
| Secondary Outcome | Adverse events, OS, TTP |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Accompanied serious diseases 2) A past history of drug allergy 3) A past history of allergic reaction to polyoxy-ethilen oil 4) Acute inflammatory disease 5) Peripheral neuropathy 6) Pregnancy or breast feeding 7) Concomitant malignancy. It influences survival, adverse events 8) Symptomatic brain metastasis 9) hypersensitivity to alcohol |
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 | Wasaburo Koizumi |
| Address | 2-1-1 Asamizodai Sagamihara-shi Kanagawa Japan Japan |
| Telephone | |
| Affiliation | Kitazato Univercity East Hospital Digestive Internal Medicine |