A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer (SLCG1301)

JRCT ID: jRCTs061180082

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 17/01/2014
• Target sample size: 90
• 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, OS, and QOL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Pathologically proven non-small cell lung cancer
2) Neither previous chemotherapy nor radiotherapy before operation
3) Complete resection
4) Pathological stage I (T>2cm)
5) LN dissection (ND2a)
6) Aged 20-75 years old enrollment
7) ECOG PS 0-1
8) Adequate organ function:
1. WBC >=3000/mm3
2. Neutrophil count >= 1,500 /mm3
3. Platelet count >= 100,000 /mm3
4. Hemoglobin >= 9.0 g/dL
5. total bilirubin <= 1.5 mg/dL
6. AST and ALT x 2.5 of upper limit of normal (ULN)
7. Creatinine clearance >=40mL/min
8. PaO2 >= 60mmHg or SpO2 >= 90%
9) At least lobectomy, within 8 weeks after surgery
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
• Secondary ID(s): UMIN000011994