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

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 - A phase II randomized trial of adjuvant chemotherapy for the patients Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001765

Enrollment

140

Registered

2009-03-12

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

A:S-1 80mg/m2 oral,day1 to 14,q3w,1year If the patient&#39

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 1ye

s Ccr estimate is 60-80mL/min, to start the first dose to reduce one level down

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)histologically conformed Non Small Cell Lung Cancer (2)pathological stage IB (T>5cm) II or IIIA completely resected by at least lobectomy (3)LN dissection (ND2a) or Elective Lymph Node Dissection (4)no prior chemotherapy or radiotherapy (5)possible to receive chemotherapy within 4-8 weeks after surgery (6)oral intake possible (7)PS of 0 or 1 (8)age 20-75 (9)adequate organ function 1)WBC>=3500/mm3<=12000/mm3 2)Neutrophil count>=2000/mm3<=8000/mm3 3)Platelet count>=100000/mm3 4)Hemoglobin>=9.0g/dl 5)AST,ALT within twice the upper limit of normal of institution 6)total bilirubin < 1.5 mg/dl 7)creatinin < 1.2 mg/dl 8)creatinin clearance>=60ml/min/body 9)PaO2>=60 torr or SpO2>=92% (10)written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
2-year desease free survival rate	—

Secondary

Measure	Time frame
overall survival,desease free survival,safety,feasibility(dose intensity included)	—

Countries

Japan

Contacts

Public ContactTokujiro Yano

Kyushu University,Graduate School of Medical Science Department of Surgery and Science

tokujiro@surg2.med.kyushu-u.ac.jp092-642-5462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T&gt;5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP