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)

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2019
INTERVENTION: S‐1 administration on Mon, Wed, Fri, and Sun S‐1 sdministration for 2 weeks, then cessation for 1 week CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Feasibility SECONDARY OUTCOME: Frequency and extent of adverse events, RFS, OS, and QOL INCLUSION 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
Epistemonikos ID: 697a228b941c0ab0416db3f4d8e7f9e1ca4cd8da
First added on: Aug 24, 2024