stage IA non-small cell lung cancer
Conditions
Interventions
Level1
52Gy/8fr, 6.5Gy/fr
Level2
62Gy/8fr, 7Gy/fr
Level3
60Gy/8fr, 7.5Gy/fr
Level4
64Gy/8fr, 8Gy/fr
Level5
68Gy/8fr, 8.5Gy/fr
Sponsors
Japanese Radiation Oncology Study Group(JROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically proven diagnosis of non-small cell lung cancer(NSCLC). 2)Diagnosed stage T1a or T1bN0M0 by imaging including CT within 35 days, FDG-PET within 60 days. 3) medically inoperable or refuse surgery 4)Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree(carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent to mediastinal or pericardial pleura also are considered central tumors and are eligible for this protocol. 5)Keep dose constraints 6)PaO2>60torr/mmHg or FEV1.0>700ml 7) No prior treatment for NSCLC 8)Age;20>, 85< 9)Eastern Cooperative Oncology Group (ECOG) performance status 0-2 10) informed consent
Exclusion criteria
Exclusion criteria: 1) Prior invasive malignancy unless disease free for a minimum of 3 years (e.g., carcinomas in situ, T1N0M0 laryngeal cancer, low risk prostate cancer;T1-2a and Gleason score 2-6 an dPSA < 10 ng/ml, stage I breast, and cancers which can expect long survalval as well as these cancers are permissible) 2)Prior radiotherapy to the region of the study cancer that would result in overlap of radiationtherapy fields; 3) Obvious interstitial pnumonitis or fibrosis on chest X-ray 4) Active infection 5)Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study 6) patients who are judged to be imppsible to participate this study due to psycologic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates ofadverse events other than a dose-limiting toxicity (DLT) which is possibly, or definitely related to treatment and which occurs within 1 year from the start of SBRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of treatment completion, incidence of late adverse effects which occurs after 1 year from the start of SBRT, the 3-year local control, recurrence of out pf field, and overall survival rates. | — |
Countries
Japan
Contacts
Public ContactTomoki Kimura
Hiroshima University Hospital Radiation Oncology
Outcome results
None listed