Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer
patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation
study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01543672.
A phase I/II multicenter trial will be conducted in patients with medically inoperable
with peripheral non small cell lung cancer (NSCLC) > 5 cm without lymph node involvement
(group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis
is expected to be dose-limiting in these patients and there is evidence that the
incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed
separately in both patient groups, using a time-to-event continual reassessment method
(TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a
minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD
constraint.
Lead OrganizationThe Netherlands Cancer Institute