T1bN0M0/T2aN0M0 Non-squamous Non-small-cell Lung Cancer
Conditions
Interventions
uracil-tegafur (250mg of tegafur per square meter of body-surface area per day) is given orally before meals for two years.
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%. 2) Clinical T1bN0M0 stage IA or T2aN0M0 stage IB (UICC TNM Classification 7th edition) 3) BED>100Gy SBRT had been selected by clinical and medical judgment or patient's choice. 4) No other treatments except SBRT have been carried out for lung cancer. 5) Tumor response is no less than SD by CT witch is recognized from 14 days until 56 days after SBRT. 6) 20<= years old 7) Performance Status (ECOG) 0-1 8) Registration was made within 56 days after SBRT. 9) The functions of the main organs are maintained, and all the criteria stated below are satisfied. (Laboratory test values made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.) * Hemoglobin: >=9.0 g/dl * WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3) * Platelet count: >=100,000/mm3 * Both AST and ALT: <=100 IU/L * Total bilirubin: <=1.5 mg/dl * Serum creatinine: <=1.5 mg/dl * PaO2: >=60 Torr or SpO2: >=90% in the state of no oxygen inhalation (room climate) 10) Patients who have estimated life expectancy longer than 2 years. Even if patient have active double cancer, patinet who can use UFT for 2 years can be included. 11) Submission of written informed consent concerning study participation.
Exclusion criteria
Exclusion criteria: 1) Other chemotherapy, radiotherapy or operation is scheduled for lung cancer after SBRT. 2) Thoracic radiotherapy or thoracic operation is scheduled. 3) severe allergy of UFT 4) serious post-SBRT complications 5) active infection, severe bone marrow suppression, severe diarrhea 6) Positive for HBs antigen or HCV antibody 7) Receiving systemic treatment of steroid or immunosuppressant 8) Other serious complications 9) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women. Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period. 10) Others judged by the investigator to be unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Adverse events Pulmonary function | — |
Countries
Japan
Contacts
Public ContactMadoka Kimura
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Thoracic Oncology
Outcome results
None listed