UMIN ID: C000000439
Registered date:01/07/2006
Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Preaviously untreated advanced advanced squamous cell lung cancer |
| Date of first enrollment | 2006/07/01 |
| Target sample size | 32 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination chemotherapy with gemcitabine and nedaplation |
Outcome(s)
| Primary Outcome | Recommended dose Dose limmiting toxicity Response Rate |
|---|---|
| Secondary Outcome | Overall survival Time to progression Toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Interstitial pneumonia or pulmonary fibrosis on chest X-P 2) peural or pericardial effusion requiring drainage 3) SVC syndrome 4) Symptomatic brain metastases 5) Active concominant malignancies 6) Uncontrolled diabetes mellitus or hypertension 7) Liver cirrhosis 8) Severe cardiovascular diseases 9) Pregnancy and lactation 10) Ccr<60ml/min 11) A history of serious drug allergy 12) Acute infection 13) Bleeding tendency 14) Unsuitable for entry to the study, decided by a medical oncologist |
Related Information
| Primary Sponsor | Department of Respiratory Medicine of Kyoto University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Katsuhiro Masago |
| Address | 54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan Japan |
| Telephone | 075-751-3830 |
| mio@kuhp.kyoto-u.ac.jp | |
| Affiliation | Kyoto unversity hospital Department of Respiratory Medicine |
| scientific contact | |
| Name | Tadashi Mio(Head),Katsuhiro Masago(Secretariat) |
| Address | 54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan Japan |
| Telephone | 075-751-3830 |
| Affiliation | Kyoto University Hospital Department of Respiratory Medicine |