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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
3-5 fractions within 10-14 days
3-5 fractions per tumor within one treatment session or sequential within one month
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Thomas Jefferson University/ Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Prinses Margaret Hospital
Toronto, Ontario, Canada
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
MLD
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.
Time frame: 4 years
loco-regional control
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Time frame: 4 years
overall survival
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Time frame: 5 years
Quality of life assessment
valuate the increase or decrease of physical discomfort.
Time frame: 2 years
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NKI-AVL
Amsterdam, Netherlands