VOLUMES Treatment of Larger Tumor Volumes or 2 Lung Metastases Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
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 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.
Heike Peulen, MD
The Netherlands Cancer Institute
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)