UMIN ID: C000000310
Registered date:23/01/2006
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small sell lung carcinoma (NSCLC) |
| Date of first enrollment | 2002/05/01 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The DC arm: Doc(60mg/m2) day1 CDDP(80mg/m2) day1 Every 3 to 4 weeks The DG arm: Doc(60mg/m2) day8 Gem(800mg/m2) day1,8 Every 3 to 4 weeks |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | Survival (1-year survival rate) Toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Proven or suspected infections diseases 2.Interstitial pneumonia (pulmonary fibrosis) manifested with chest radiogram and symptoms 3.Uncontrolable complications of heart, liver, DM, bleeding, etc. 4.Peripheral neuropathy of grade 2 or severer 5.Pleural fluid requiring treatment 6.Pericardial fluid 7.Symptomatic brain metastasis 8.Active concomitant malignancy 9.Pregnancy, breast feeding or wish of future bearing 10.History of drug allergy 11.Myocardial infarction within 3 months 12.Requirement of emergency radiotherapy 13.Other conditions not suitable for this study |
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 | Hisanobu Niitani |
| Address | 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan Japan |
| Telephone | |
| Affiliation | The Tokyo cooperative oncology group Chief director |