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

Primary Purpose

Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole brain radiation
Stereotactic radiation (SRS)
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Brain metastases, Brain metastasis, Lung cancer, Melanoma, Breast cancer, Kidney cancer, Renal cell carcinoma, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic, Whole brain radiation, WBRT, Hippocampal avoidance, Hippocampal sparing, Hippocampal, Hippocampus, Radiation, Quality of Life, Neurocognitive, Neurocognition, Survival, Salvage, MDASI, Chemotherapy, Recurrence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Whole Brain Radiation

Stereotactic Radiation (SRS)

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Quality of Life Survey (symptoms and interference)
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Secondary Outcome Measures

Overall survival
Clinical Parameter
Neurologic survival
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
Incidence and time to detection of new brain metastases
Radiographic assessment of first appearance of new brain metastases
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
Incidence and time to development of radiation necrosis
Radiographic assessment of first appearance of radiation necrosis
Incidence and time to development of leptomeningeal disease
Radiographic assessment of first appearance of leptomeningeal disease
Incidence and time to salvage craniotomy
Clinical assessment of first use of neurosurgical resection as salvage therapy
Incidence and time to additional radiotherapeutic treatments
Clinical assessment of first use of salvage brain-directed radiation
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
Incidence and time to neurocognitive decline
Scale
Performance status
Questionnaire - Karnofsky performance status

Full Information

First Posted
March 1, 2017
Last Updated
September 21, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03075072
Brief Title
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Brain metastases, Brain metastasis, Lung cancer, Melanoma, Breast cancer, Kidney cancer, Renal cell carcinoma, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic, Whole brain radiation, WBRT, Hippocampal avoidance, Hippocampal sparing, Hippocampal, Hippocampus, Radiation, Quality of Life, Neurocognitive, Neurocognition, Survival, Salvage, MDASI, Chemotherapy, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Brain Radiation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stereotactic Radiation (SRS)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Radiation
Intervention Name(s)
Whole brain radiation
Intervention Description
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation (SRS)
Intervention Description
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.
Primary Outcome Measure Information:
Title
Quality of Life Survey (symptoms and interference)
Description
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Clinical Parameter
Time Frame
Through study completion, an average of 1 year
Title
Neurologic survival
Description
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to detection of new brain metastases
Description
Radiographic assessment of first appearance of new brain metastases
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to local recurrence of treated brain tumor(s)
Description
Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to development of radiation necrosis
Description
Radiographic assessment of first appearance of radiation necrosis
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to development of leptomeningeal disease
Description
Radiographic assessment of first appearance of leptomeningeal disease
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to salvage craniotomy
Description
Clinical assessment of first use of neurosurgical resection as salvage therapy
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to additional radiotherapeutic treatments
Description
Clinical assessment of first use of salvage brain-directed radiation
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to the development of seizures
Description
Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review
Time Frame
Through study completion, an average of 1 year
Title
Incidence and time to neurocognitive decline
Description
Scale
Time Frame
1 year
Title
Performance status
Description
Questionnaire - Karnofsky performance status
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayal Aizer, MD
Phone
617-732-7560
Email
aaaizer@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ivy Ricca, BA
Phone
6175828927
Email
iricca@mgb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD MHS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD MHS
Phone
617-732-7560
Email
aaaizer@partners.org
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD MHS
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD
Phone
617-732-7560
Email
aaaizer@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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