Transcription of JCOG1201/TORG1528
1 Japan Clinical Oncology Group / Thoracic Oncology Research Group 29-A-3 JCOG JCOG1201/TORG1528 + (CE ) + (CI ) II/III ver. A Phase II/III Study Comparing Carboplatin and Irinotecan (CI) with Carboplatin and Etoposide (CE) for the Treatment of Elderly Extended-Stage Small-Cell Lung Cancer ED-SCLC/CI vs. CE JCOG TORG 240-8555 56 240-8555 56 2012 3 3 JCOG PC1201 2013 11 5 JCOG 2014 6 5 ver.
2 JCOG 6 9 2016 1 7 ver. JCOG 1 19 2016 1 7 ver. TORG 1 19 JCOG1201/TORG1528 ver. 2/101 2018 10 24 ver. JCOG 2018 10 31 ver. TORG 2018 11 26 ver. JCOG 2018 12 6 JCOG1201/TORG1528 ver. 3/101 0. 29 16 JCOG + (CE ) + (CI ) II/III CE CI II/III ED-SCLC CI CE II/ III II Primary endpoint CI Secondary endpoint III Primary endpoint Secondary endpoints Symptom Score 1 WHO 1999 LCNEC class IV class V 2 CT CT MRI CT PET ED CT MRI 3 1 1 4 71
3 5 Performance status PS ECOG 0 2 PS 6 7 JCOG1201/TORG1528 ver. 4/101 8 1 1 9 14 2 3,000 /mm3 1,500 /mm3 14 10 104 /mm3 mg/dL AST GOT 100 IU/L ALT GPT 100 IU/L mg/dL 50 mL/min Cockcroft-Gault 50 mL/min 50 mL/min Cockcroft-Gault CCr= 140- kg / 72 mg/dL CCr= 140- kg / 72 mg/dL SpO2 92% SpO2 92% PaO2 60 torr 10 2 2 11 A CE 3 1 4 AUC 5 30 60 / day 1 80 mg/m2 60 120 / day 1 2 3 B CI 3 1 4
4 AUC 4 30 60 / day 1 50 mg/m2 60 90 / day 1 8 370 5 ver. 256 1 9 2013 12 17 2022 12 17 CRF JCOG TORG JCOG SS SS
