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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)

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

NCT ID

NCT03075072

First Posted

March 1, 2017

Last Updated

September 21, 2023

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

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

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

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

aaaizer@partners.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ivy Ricca, BA

Phone

6175828927

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

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

aaaizer@partners.org

12. IPD Sharing Statement

Plan to Share IPD

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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