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

Istituto Clinico Humanitas

Status: Completed

Conditions: Brain Metastases

Treatments: Radiation: brain metastatic patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02576522

1408

Details and patient eligibility

About

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

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

brain metastatic patients

Experimental group

Description:

Patients with single, large brain metastases from solid tumors

Treatment:

Radiation: brain metastatic patients