local advanced Non-small cell Lung Cancer(non-squamous)
Conditions
Interventions
Combination of carboplatin:AUC=5 or 6 plus pemetrexed(500mg/m2) with concurrent thoracic radiotherapy 2Gy/day for 30 times
Sponsors
Central Japan Lung Study Group(CJLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient with pathologically proven non-small cell lung cancer (except for squamous cell carcinoma). 2) Patient with stage III desease who has not been previously treated for lung cancer, including chemotherapy, radiotherapy, and operation 3) Patient who are not candidates for curative operation. 4) Patient who has at least one or more measurable lesion by RECIST. ver.1.1 . 5) An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 6) Patient aged 20-74 years old 7) ECOG performance status (PS): 0-1 8) Adequate organ function. 9) Patient who are considered to survive for more than 3 months. 10) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Superior vena cava syndrome. 2) Lymph node metastases of opposite side hilum, malignant pleuritis, malignant pericarditis, lymphangitis. 3) Active infection or other serious disease condition (poorly controlled diabetes mellitus, unstable angina, cardiac infarction, psychological illness, etc.). 4) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 5) With active double cancer. 6) Patient who joins other trial. 7) HBs antigen positive. 8) Severe drug allergy. 9) Pregnancy or lactation. 10) Patient whose participation in the trial is judged to be inappropriate by the attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : Safety Dose determination Phase II : 2-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I : Response rate Phase II : Progression free survival, response rate, disease control rate | — |
Countries
Japan
Contacts
Public ContactNaohiko Murata
Central Japan Lung Study Group(CJLSG) Management office
Outcome results
None listed