UMIN ID: C000000035
Registered date:04/09/2005
A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Stage IIIB/IV Non-small cell lung cancer |
| Date of first enrollment | 2004/04/01 |
| Target sample size | 600 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Platinum doublet chemotherapy more than 3 cycles up to 6 cycles. Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases. |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease |
Related Information
| Primary Sponsor | West Japan Thoracic Oncology Group (WJTOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | West Japan Thoracic Oncology Group (WJTOG) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | West Japan Thoracic Oncology Group (WJTOG) West Japan Thoracic Oncology Group (WJTOG) |
| scientific contact | |
| Name | Toyoaki Hida |
| Address | 1-1 Kanokoden, Chikusa-ku, Nagoya Japan |
| Telephone | |
| Affiliation | Aichi cancer center hospital Department of Thoracic Oncology |