A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: Induction concurrent chemoradiotherapy (CDDP +TS‐1+ RT50Gy) The surgical resection is performed after 2 cycles of chemotherapy with CDDP, TS‐1 and RT50Gy. CONDITION: Stage IIIA‐N2 non‐small cell lung cancer PRIMARY OUTCOME: 2‐year overall survival SECONDARY OUTCOME: Overall survival; Progression‐free survival; Postoperative recurrence free survival; Response rate; Pathological complete response rate; Frequency and grade of adverse event INCLUSION CRITERIA: 1)Histologically or cytologically proven non‐small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node 2)Stage IIIA‐ resectable N2 disease without previously treatment for lung cancer 3)Age>=20, <75 y 4)Patient who can ingest orally 5)ECOG PS 0‐1 6)Adequate organ function neutrophil count>=2,000/mm3 blood platelet count>=100,000/mm3 hemoglobin>=9.0g/dL total bilirubin<=1.5mg/dL AST,ALT<=100IU/L PaO2>=60Torr or SpO2>=94% CCr>=60ml/min 7)Written informed consent
Epistemonikos ID: 575d23267155f348876e0d11e47fffdd55981953
First added on: Aug 23, 2024