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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576522
• Other study ID #: 1408
• Status: Completed
• Phase: N/A
• Start date: June 29, 2015
• Est. completion date: January 22, 2019

Study information

• Verified date: May 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• brain metastatic patients
Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate		6 months
Secondary	Distant brain failure		6 months
Secondary	Overall survival, statistical		6 months
Secondary	Morbidity/mortality after surgery		1 month
Secondary	Radionecrosis after treatments		6 months
Secondary	Neuropsycological alterations after treatments, questionnaire		6 months