Non-small cell lung cancer (NSCLC), pulmonary metastases Non-small cell lung cancer, Central lung tumor, Pulmonary metastasis, Oligometastases, Stereotactic body radiotherapy
Conditions
Interventions
Dose-escalation stereotactic body radiotherapy (SBRT) for central lung tumors using a 3+3 design. Radiation dose levels are 60 Gy/10 fractions, 65 Gy/10 fractions, and 70 Gy/10 fractions.
SBRT, Stereotactic body radiotherapy, Dose escalation, Radiation therapy
Sponsors
Yamashita Hideomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or clinically diagnosed primary or recurrent non-small cell lung cancer (NSCLC), or limited pulmonary metastases. 2. Tumor diameter 5 cm or less. 3. For primary or recurrent NSCLC, no lymph node or distant metastases. 4. For pulmonary metastases, oligometastatic disease with 3 or fewer pulmonary lesions and controlled primary and extrapulmonary disease. 5. Central lung tumor located within 2 cm of the proximal bronchial tree, trachea, esophagus, heart, major vessels, brachial plexus, or spinal cord. 6. Feasible treatment planning meeting all protocol defined dose constraints. 7. ECOG performance status 0-2. 8. Age 18 years or older. 9. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: Patients with lymph node metastasis or distant metastasis. Patients scheduled to receive concurrent systemic therapy for the primary disease. Patients with a history of prior thoracic radiotherapy. Patients with active interstitial pneumonia or pulmonary fibrosis on chest CT. Patients suspected of having interstitial lung disease, such as those with elevated KL-6 levels, whom the principal investigator judges unsuitable for study participation. Patients with severe pulmonary dysfunction for whom the principal investigator or subinvestigator determines that SBRT cannot be safely administered. Pregnant or breastfeeding patients. Patients participating in another clinical trial that may affect the conduct or results of this study. Patients whom the principal investigator or subinvestigator considers unsuitable for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLT) within 90 days after completion of radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| LC LR-PFS PFS OS Adverse events MTD RD | — |
Contacts
Public ContactAkiko Oka
University of tokyo hospital
Outcome results
None listed