Non-Small Cell Lung Cancer
Conditions
Interventions
An oral dose of 250mg of gefitinib is administered daily beginning on day 1, with once-daily thoracic radiotherapy delivered at 2 Gy per day to a total dose of 64 Gy.
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed NSCLC 2) Treatment naïve, unresectable stage III disease, whereas those with T3N1 desease, contralateral mediastinal lymph node metastasis, pulmonary metastasis, and atelectasis of the entire hemithorax were excluded 3) Harboring EGFR mutation (exon 19 deletion, and / or exon 21 L858R point mutation) 4) an age of 20-75 years 5) ECOG PS of 0 or 1 6)With evaluable target lesions as per RECIST ver. 1.1 7) With adequate organ function 8) Confirmed as eligible for the protocol defined radiotherapy by radiologists 9) Provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Harboring exon 20 T790M mutation. 2) Incapable of oral intake 3) With intestinal paralysis, or ileus 4) Chronic diarrhea 5)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 6) Active infection 7) Positive for HBs antigen 8) Uncontrolled diabetes mellitus 9) Severe heart disease 10) Systemic treatment with steroids 11) Concomitant cancers within 5 years 12) Prior history of thoracic radiotherapy 13) History of sereous drug allegies 14) Pregnancy, breast feeding, or hesitation in contraception 15) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, progression free survival rate at 1 year, progression free survival, survival rate at 1 year, survival rate at 2 years, overall survival, and safety. | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed