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

Not Applicable

Completed

• Conditions: Brain Metastases
• Interventions: Radiation: brain metastatic patients

• Registration Number: NCT02576522
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2015-06-29
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-12
• Study First Posted: 2015-10-15
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
brain metastatic patients	brain metastatic patients	Patients with single, large brain metastases from solid tumors

Primary Outcome Measures

Name	Time	Method
Local control rate	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy