UMIN ID: UMIN000001765
Registered date:12/03/2009
A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T>5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | non-small cell lung cancer |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 140 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A:S-1 80mg/m2 oral,day1 to 14,q3w,1year If the patient's Ccr estimate is 60-80mL/min,to start the first dose to reduce one level down B:S-1 80mg/m2 oral day1 to 21,q5w+CDDP 60mg/m2 day8,q5w,4 courses,followed by S-1 80mg/m2 oral day1 to 14,q3w,total 1year If the patient's Ccr estimate is 60-80mL/min, to start the first dose to reduce one level down |
Outcome(s)
| Primary Outcome | 2-year desease free survival rate |
|---|---|
| Secondary Outcome | overall survival,desease free survival,safety,feasibility(dose intensity included) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)A history of severe allergic reactions to drugs (2)Patients who have already received CDDP,S-1 (3)myocardial infarction within 6 months (4)apparent interstitial pneumonitis or pulmonary fibrosis (5)Patients with an unstable or serious heart disease (6)Patients with an unstable or serious psychic disease (7)uncontrolled diabetes mellitus (8)Patients with Paralysis of intestine or ileus (9)Patients with an active infection (10)Patients with other severe complication (11)The presence of other concomitant or metachronous cancers (12)Pregnant or expecting or lactating woman (13)Male patient who intends to make someone pregnant during this study (14)Patient who requires continuous use of flucytosine , phenytoin or warfarin potassium (15)systemic steroid therapy required (16)Patient who is judged to be inappropriate as subject to this study by the principal investigator |
Related Information
| Primary Sponsor | Kyushu University,Graduate School of Medical Science,Department of Surgery and Science |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyushu University,Graduate School of Medical Science,Department of Surgery and Science |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tokujiro Yano |
| Address | 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN Japan |
| Telephone | 092-642-5462 |
| tokujiro@surg2.med.kyushu-u.ac.jp | |
| Affiliation | Kyushu University,Graduate School of Medical Science Department of Surgery and Science |
| scientific contact | |
| Name | Yoshihiko Maehara |
| Address | 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN Japan |
| Telephone | 092-642-5462 |
| Affiliation | Kyushu University,Graduate School of Medical Science Department of Surgery and Science |