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

October 22, 2024 updated by: Ayal Aizer, MD, Dana-Farber Cancer Institute

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02116
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole Brain Radiation
  • MRI will be performed prior to radiation is administered
  • A hippocampal sparing approach will be used when possible
  • Dose will be 30 Gy in 10 fractions
Radiation: Whole brain radiation
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
Experimental: Stereotactic Radiation (SRS)
  • MRI will be performed prior to radiation is administered
  • Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)
Radiation: Stereotactic radiation (SRS)
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Survey (symptoms and interference)
Time Frame: 6 months
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Through study completion, an average of 1 year
Clinical Parameter
Through study completion, an average of 1 year
Neurologic survival
Time Frame: Through study completion, an average of 1 year
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
Incidence and time to detection of new brain metastases
Time Frame: Through study completion, an average of 1 year
Radiographic assessment of first appearance of new brain metastases
Through study completion, an average of 1 year
Incidence and time to local recurrence of treated brain tumor(s)
Time Frame: Through study completion, an average of 1 year
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
Incidence and time to development of radiation necrosis
Time Frame: Through study completion, an average of 1 year
Radiographic assessment of first appearance of radiation necrosis
Through study completion, an average of 1 year
Incidence and time to development of leptomeningeal disease
Time Frame: Through study completion, an average of 1 year
Radiographic assessment of first appearance of leptomeningeal disease
Through study completion, an average of 1 year
Incidence and time to salvage craniotomy
Time Frame: Through study completion, an average of 1 year
Clinical assessment of first use of neurosurgical resection as salvage therapy
Through study completion, an average of 1 year
Incidence and time to additional radiotherapeutic treatments
Time Frame: Through study completion, an average of 1 year
Clinical assessment of first use of salvage brain-directed radiation
Through study completion, an average of 1 year
Incidence and time to the development of seizures
Time Frame: Through study completion, an average of 1 year
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
Incidence and time to neurocognitive decline
Time Frame: 1 year
Scale
1 year
Performance status
Time Frame: Through study completion, an average of 1 year
Questionnaire - Karnofsky performance status
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Ayal Aizer, MD MHS, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Estimated)

November 7, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 4, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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