UMIN ID: UMIN000000608
Registered date:01/04/2007
Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Stage IIIB/IV or ppstoperative recurrent non-small sell lung cancer |
| Date of first enrollment | 2007/04/01 |
| Target sample size | 600 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | CDDP: 80mg/m2 day1 Docetaxel: 60mg/m2 day1 q3-4weeks Doc(60mg/m2) day8 TS-1(800mg/m2) day1-21 q4-5weeks |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | PFS TTF Response rate Adverse event QOL |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.With adjuvant chemotherapy 2.History of serious drug allergy 3.Active concomitant malignancy 4.Serious complications 5.Proven or suspected infections diseases 6.Symptomatic brain metastasis 7.Watery diarrhea or Chronic constipation 8.Pleural effusion,peritoneal fluid,and pericardial fluid 9.Concomitant therapy with another anticancer drug or flucytocine 10.Pregnancy,breast feeding or wish of future bearing 11.Mental disease or psychotic manifestation 12.It participated in the development clinical trial of and others within 1 month 13.Other conditions not suitable for this study |
Related Information
| Primary Sponsor | The Tokyo cooperative oncology group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | TAIHO Fharmaceutical CO.,LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | The Tokyo cooperative oncology group Clinical Study Promotion Agency |
| scientific contact | |
| Name | Shoji Kudo |
| Address | 3-1-24 Matsuyama Kiyose-City Tokyo,Japan Japan |
| Telephone | |
| Affiliation | Fukujuji Hospital Director |