UMIN ID: C000000133
Registered date:12/09/2005
Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | platinum-pretreated patients with non-small-cell lung cancer |
| Date of first enrollment | 2005/09/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination chemotherapy of S-1 and docetaxel Single-agent of docetaxel |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | progression-free survival, overall survival, quality of life, adverse events |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Active concomitant malignancy Active Interstitial pneumonia Massive effusions Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Inappropriate condition for this study judged by physicians. |
Related Information
| Primary Sponsor | Okayama Lung Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nagio Takigawa |
| Address | 2-5-1 Shikata-cho, Okayama 700-8558 Japan |
| Telephone | 086-235-7227 |
| ntakigaw@md.okayama-u.ac.jp | |
| Affiliation | Okayama Lung Cancer Study Group Coordinating Office Department of Respiratory Medicine, Okayama University Hospital |
| scientific contact | |
| Name | Mitsune Tanimoto |
| Address | 2-5-1 Shikata-cho, Okayama 700-8558 Japan |
| Telephone | 086-235-7227 |
| Affiliation | Okayama University Hospital Hematology, Oncology, Respiratory Medicine |