UMIN ID: UMIN000001928
Registered date:01/05/2009
Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small cell lung cancer |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 35 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Preoperatively induction chemotherapy (CDDP/S-1) |
Outcome(s)
| Primary Outcome | Analysis of regulation factors from lymph node samples usng EBUS-TBNA and relation to radiological, histological response rate after induction chemotherapy |
|---|---|
| Secondary Outcome | feasibility, progression free survival, overall survival,and safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Patients with severe drug allergy 2)Patients with administration of another 5-fluouracil derivative drugs, flucytosine, phenytoin, warfarin sodium 3)Patients with active concomitant malignancy 4)Patients with active severe infection, diarrhea, interstinalparalysis, ileus, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months from onset, heart failure, other severe complications 5)Patients with active lung disease such as idopathic pulmonary fibrosis, pulmonary emphysema, severe chronic bronchitis, bronchial asthma 6)Patients with uncontrollable psychiatrical complications |
Related Information
| Primary Sponsor | Thoracic Surgery, Graduate School of Medicine, Chiba University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Thoracic Surgery, Graduate School of Medicine, Chiba University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Graduate School of Medicine, Chiba University Thoracic Surgery |
| scientific contact | |
| Name | Ichiro Yoshino |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba Japan |
| Telephone | |
| Affiliation | Graduate School of Medicine, Chiba University Thoracic Surgery |