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Brief Title: Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously
Official Title: VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
Study ID: NCT01543672
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Bayern, Germany
NKI-AVL, Amsterdam, , Netherlands
Name: Heike Peulen, MD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR