A randomized phase II study of TS-1 adjuvant chemotherapy for the elderly patient with completely resected NSCLC (SLCG1201)

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-jRCTs061180089
• Lead Sponsor: Toyooka Shinichi

Brief Summary

Alternate-day oral administration of S-1 for 1 year as adjuvant chemotherapy was demonstrated to be feasible with low toxicity in completely resected pathological stage IA (tumor diameter > 2 cm), IB, II and IIIA NSCLC

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Study Completion: 2021-05-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility

Secondary Outcome Measures

Name	Time	Method
Frequency and extent of adverse events, RFS, and OS