UMIN ID: C000000287
Registered date:18/11/2005
A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Locally Advanced Non-Small Cell Lung Cancer |
| Date of first enrollment | 2003/06/01 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy A: UFT:400mg/m2,p.o.,d1-14 Cisplatin: 80mg/m2,div,d8 every 3-4weeks UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy B: Docetaxel:60mg/m2,div,d1 every 3weeks |
Outcome(s)
| Primary Outcome | Survival |
|---|---|
| Secondary Outcome | Response rate, TTP, Safety, Compliance |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)bronchopulmonary lymph node metastasis 2) Pleural or pericardial effusion requiring treatment 3) Concomitant malignancy 4) Serious concomitant disease 5)Apparent ineterstitial pneumonia or pulmonary fibrosis 6)Pregnant or lactation women, or women with known or suspected pregnancy. Man who wont let to pregnancy |
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 | National Kyushu Cancer Center Respiratory |
| scientific contact | |
| Name | Yukito Ichinose |
| Address | 3-1-1 Notame Mimami-ku Fukuoka-shi Fukuoka Japan Japan |
| Telephone | |
| Affiliation | National Kyushu Cancer Center National Kyushu Cancer Center |