Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

Brain Metastases Clinical Trial

Official title:

Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075072
• Other study ID #: 16-305
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: Dana-Farber Cancer Institute
• Contact: Ayal Aizer, MD
• Phone: 617-732-7560
• Email: aaaizer[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

Description:

This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.

In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible

• Five-twenty intracranial lesions must be present on MRI of the brain

• Age 18-80 years at diagnosis of brain metastases

• Karnofsky performance status of at least 70

Exclusion Criteria:

• Participants who have undergone prior radiation for brain metastases.

• Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study

• Participants who cannot undergo a brain MRI

• Participants who cannot receive gadolinium (MRI contrast)

• Participants with stage IV-V chronic kidney disease or end stage renal disease

• Participants with widespread, definitive leptomeningeal disease

• Participants with small cell lung cancer, lymphoma, or myeloma

• Participants with a maximum tumor diameter exceeding 5 cm (if not resected)

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• Whole brain radiation
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
• Stereotactic radiation (SRS)
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Survey (symptoms and interference)	Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)	6 months
Secondary	Overall survival	Clinical Parameter	Through study completion, an average of 1 year
Secondary	Neurologic survival	Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)	Through study completion, an average of 1 year
Secondary	Incidence and time to detection of new brain metastases	Radiographic assessment of first appearance of new brain metastases	Through study completion, an average of 1 year
Secondary	Incidence and time to local recurrence of treated brain tumor(s)	Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation	Through study completion, an average of 1 year
Secondary	Incidence and time to development of radiation necrosis	Radiographic assessment of first appearance of radiation necrosis	Through study completion, an average of 1 year
Secondary	Incidence and time to development of leptomeningeal disease	Radiographic assessment of first appearance of leptomeningeal disease	Through study completion, an average of 1 year
Secondary	Incidence and time to salvage craniotomy	Clinical assessment of first use of neurosurgical resection as salvage therapy	Through study completion, an average of 1 year
Secondary	Incidence and time to additional radiotherapeutic treatments	Clinical assessment of first use of salvage brain-directed radiation	Through study completion, an average of 1 year
Secondary	Incidence and time to the development of seizures	Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review	Through study completion, an average of 1 year
Secondary	Incidence and time to neurocognitive decline	Scale	1 year
Secondary	Performance status	Questionnaire - Karnofsky performance status	Through study completion, an average of 1 year