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

JRCT ID: jRCTs061180089

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 31/05/2012
• Target sample size: 100
• Study type: Interventional

Intervention(s)

S-1 administration on Mon, Wed, Fri, and Sun
S-1 sdministration for 2 weeks, then cessation for 1 week

Outcome(s)

• Primary Outcome: Feasibility
• Secondary Outcome: Frequency and extent of adverse events, RFS, and OS

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Toyooka Shinichi
• Source(s) of Monetary Support: ECRIN
• Secondary ID(s): UMIN000007819