Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02576522

Enrollment

Registered

2015-10-15

Start date

2015-06-29

Completion date

2019-01-22

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

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.

Interventions

RADIATIONbrain metastatic patients

Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

* Prior WBRT * KPS ≤ 70 * Other primary cancer * Pregnant women

Design outcomes

Primary

Measure	Time frame
Local control rate	6 months

Secondary

Measure	Time frame
Distant brain failure	6 months
Overall survival, statistical	6 months
Morbidity/mortality after surgery	1 month
Radionecrosis after treatments	6 months
Neuropsycological alterations after treatments, questionnaire	6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026