UMIN ID: UMIN000001227
Registered date:07/07/2008
Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | chamotherapy-naive advanced squamous cell carcinoma of the lung |
| Date of first enrollment | 2006/04/01 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | combination chemotherapy of nedaplatin and docetaxel |
Outcome(s)
| Primary Outcome | Response rate (phase II study) |
|---|---|
| Secondary Outcome | one year survival rate, overall survival, progression free survival, adverse event |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Pre-existing pulmonary fibrosis (chest Xray) 2)Previous history of another cancer 3)Uncontrolled comorbidities 4)Active infection 5)Pregnancy or lactation 6)Symptomatic brain metastases 7)Allergy to polysorbate 80 8)Considered unfit for trial by own physician |
Related Information
| Primary Sponsor | National Cancer Center Hospital East Thoracic Oncology Division |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoichi Naito |
| Address | 6-5-1 Kashiwanoha Kashiwa Chiba Japan Japan |
| Telephone | 0471-33-1111 |
| ynaito@east.ncc.go.jp | |
| Affiliation | National Cancer Center Hospital East Thoracic Oncology Division |
| scientific contact | |
| Name | Yutaka Nishiwaki |
| Address | 6-5-1 Kashiwanoha Kashiwa Chiba Japan Japan |
| Telephone | 0471-33-1111 |
| Affiliation | National Cancer Center Hospital East Thoracic Oncology Division |