Spots Global Cancer Trial Database for Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

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Trial Identification

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

Conditions

Lung Cancer

Metastatic Lung Cancer

Interventions

Stereotactic Body Radiotherapy (SBRT)

Study Description

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.