UMIN ID: UMIN000001826
Registered date:31/03/2009
Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced non-small cell lung cancer |
| Date of first enrollment | 2009/04/01 |
| Target sample size | 860 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Docetaxel alone Docetaxel and S-1 |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | Progression free survival Adverse events Response rate |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1) Patients with serious infections or suspected infections with fever. 2) Pregnant or lactating women 3) Active concomitant malignancy 4) sever allergy 5) Active ineterstitial pneumonitis 6) The prior treatment is a case only of the molecular-targeted agent. 7) Symptomatic brain metastasis 8) History of using 5-FU or docetaxel 9) Inappropriate patients for this study judged by the physicians. |
Related Information
| Primary Sponsor | The Japan-multinational Trial Organization |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Japan-multinational Trial Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 075-241-4894 |
| Affiliation | The Japan-multinational Trial Organization The Japan-multinational Trial Organization |
| scientific contact | |
| Name | Masaaki Kawahara |
| Address | 1180 Nagasone, Kitaku, Sakai, Osaka, Japan Japan |
| Telephone | 06-6972-1181 |
| Affiliation | National Hospital Organization Kinki-chuo Chest Medical Center Internal Medicine |