NCT01543672

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Metastatic Lung Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy (SBRT)	3-5 fractions within 10-14 days
RADIATION	Stereotactic Body Radiotherapy (SBRT)	3-5 fractions per tumor within one treatment session or sequential within one month

Timeline

• Start date: 2011-11-22
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2012-03-05
• Last updated: 2019-06-27

Locations

5 sites across 4 countries: United States, Canada, Germany, Netherlands