Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer - Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011694

Enrollment

Registered

2013-09-11

Start date

2012-07-01

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

Carboplatin AUC 5 is administered by an infusion lasting 60 minutes on day 1 and S-1 is administered twice a day on day1-14. Every 3 weeks for 4 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically determined non-small cell lung cancer. 2) Pathological stageIIA, IIB, IIIA. Completely resected. 3) Neither previous chemotherapy nor radiotherapy before operation. 4) ECOG performance status 0 or 1. 5) Aged 20-75 years old. 6) Adequate organ function. White blood cell count >= 4,000 /mm3 Neutrophil count >= 1,500 /mm3 Hemoglobin >= 9.0 g/dL Platelet count >= 100,000 /mm3 AST and ALT <= 100 IU/L Total bilirubin <or= 1.5 mg/dL Serum creatinine <= 1.25 mg/dL PaO2 >= 60.0 torr 7) Patients are excepted to live at least 3 months 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, controlled diabetes, infection, psychiatric disorder). 3) Patients who are pregnant,considering pregnancy oractaing. 4) Receiving systemic treatment of steroid or immunosuppressant. 5) History of active double cancerwithin 5years prior to the study. 6) Other conditions not suitable forthis study.

Design outcomes

Primary

Measure	Time frame
Accomplishment of 3 course treatment	—

Secondary

Measure	Time frame
Safty, 2yr RFS	—

Countries

Japan

Contacts

Public ContactHisashi Tanaka

Hirosaki University Graduate School of Medicine Department of Cardiology, Respiratory Medicine and Nephrology

h-tanaka@cc.hirosaki-u.ac.jp0172-39-5057

Outcome results

None listed

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