Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 2

Conditions

Metastatic Malignant Neoplasm in the Brain

Treatments

Radiation: Frameless Fractionated Stereotactic Radiation Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02798029

NCI-2016-01180 (Registry Identifier)

2015-0874 (Other Identifier)

Details and patient eligibility

About

This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.

Full description

PRIMARY OBJECTIVES:

I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS).

SECONDARY OBJECTIVES:

I. To assess 6-month local control, intracranial progression-free survival and overall survival.

II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS.

OUTLINE:

Patients undergo FFSRT daily over 30 minutes for 3-5 days.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS
One to 4 untreated metastatic brain lesions
Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate
Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
Histologic confirmation of malignancy
For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging
No concurrent chemotherapy
Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol.

Exclusion criteria

Five or more metastatic brain lesions
Brain lesion(s) greater than 5 cm in diameter
Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)
Patients unable to have IV contrast for computed tomography (CT) and MRI imaging
Patient unable to have an MRI of the brain
Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
Positive pregnant status confirmed by serum or urine pregnancy test
Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
Prior whole brain radiotherapy or conventional external beam radiotherapy