Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously — VOLUMES  

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Lung Cancer

• NCT number: NCT01543672
• Study type: Interventional
• Source: The Netherlands Cancer Institute
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 22, 2011
• Completion date: October 31, 2017