A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer

A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer - A randomized phase II study of TS-1 adjuvant chemotherapy for the elderly patient with completely resected NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007819

Enrollment

100

Registered

2012-04-25

Start date

2012-05-01

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:TS-1 alternate-day administrations

TS-1 is administered orally at Monday, Wednesday, Friday and Sunday for one year. B:TS-1 day1-14, q1w for one year

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically proven non-small cell lung cancer 2) Complete resection 3) Pathological stage IA(T1bN0M0)-IIIA 4) At least lobectomy, within 8 weeks after surgery 5) LN dissection (ND2a) 6) Neither previous chemotherapy nor radiotherapy before operation 7) Age of 75 years or older at the time of enrollment 8) ECOG PS 0-1 9) Adequate organ function: i) WBC >=3000/mm3 and <=12000/mm3, ii) PaO2 >= 60mmHg or SpO2 >= 90% iii) Platelets >=100,000/mm3, iv) Hemoglobin >=9.0g/dL, v) Total bilirubin <=1.5mg/dL, vi) AST(GOT)/ALT(GPT) <=100IU/L, vii) Creatinine clearance >=40mL/min. viii) Creatinine < 1.2mg/dl 10) Signed informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against S-1 2) Severe myelosuppression, renal dysfunction or liver dysfunction 3) Usage of other fluorinated pyrimidine drugs 4) Usage of flucytosine 5) Severe drug allergy 6) Unstable angina or Myocardial Infarction within 6 months 7) Apparent interstitial pneumonitis or pulmonary fibrosis at chest rentogenogram 8) Concomitant therapy Warfarin Potassium or Dabigatran 9) Abnormality of EGG or UCG 10) Severe heart disease, serious psychiatric illness, severe infection, severe other complications 11) Uncontrolled Diabetes Mellitus 12) Ileus 13) Diarrhea 14) Uncontrolled cancer 15) HBs antigen positive 16) Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

Measure	Time frame
Feasibility (treatment completion rate), which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more.	—

Secondary

Measure	Time frame
toxicity, RFS, and OS	—

Countries

Japan

Contacts

Public ContactHiromasa Yamamoto

Setouchi Lung Cancer Group Department of Thoracic Surgery, Okayama University Hospital

h.yamamoto@md.okayama-u.ac.jp086-223-7151

Outcome results

None listed

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