Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor

Istituto Clinico Humanitas1 site in 1 country87 target enrollmentJune 29, 2015

ConditionsBrain Metastases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Metastases
Sponsor: Istituto Clinico Humanitas
Enrollment: 87
Locations: 1
Primary Endpoint: Local control rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

Detailed Description

Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

Registry

clinicaltrials.gov

Start Date

June 29, 2015

End Date

January 22, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Istituto Clinico Humanitas

Responsible Party

Principal Investigator

Michele Tedeschi

Istituto Clinico Humanitas

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years
•Karnosky performance status (KPS) ≥70
•All Solid tumor (esclusion SCLC and Germinal tumors)
•Controlled primary tumor
•Controlled other metastatic site
•Single metastatic lesion at diagnosis
•Lesions ≥ 2.1 cm in maximum diameter (4 cm3), \< 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
•Estimated survival ≥ 3 months.
•Written informed consent