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

This study is currently recruiting participants.
Verified November 2017 by Ayal Aizer, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03075072
First Posted: March 9, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ayal Aizer, Dana-Farber Cancer Institute
  Purpose
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)

Condition Intervention Phase
Brain Metastases Radiation: Whole brain radiation Radiation: Stereotactic radiation (SRS) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ayal Aizer, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ]
    Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Through study completion, an average of 1 year ]
    Clinical Parameter

  • 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)

  • 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

  • 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 5-15 brain metastases that were initially treated with radiation

  • 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

  • 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

  • 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

  • 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

  • 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

  • Incidence and time to neurocognitive decline [ Time Frame: 1 year ]
    Scale

  • Performance status [ Time Frame: Through study completion, an average of 1 year ]
    Questionnaire - Karnofsky performance status


Estimated Enrollment: 196
Actual Study Start Date: April 10, 2017
Estimated Study Completion Date: March 30, 2022
Estimated Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-fifteen 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075072


Contacts
Contact: Ayal Aizer, MD 617-732-7560 aaaizer@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ayal Aizer, MD MPH    617-732-7560    aaaizer@partners.org   
Principal Investigator: Ayal Aizer, MD MHS         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02116
Contact: Ayal Aizer, MD    617-732-7560    aaaizer@partners.org   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Ayal Aizer, MD MHS Brigham and Women's Hospital
  More Information

Responsible Party: Ayal Aizer, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03075072     History of Changes
Other Study ID Numbers: 16-305
First Submitted: March 1, 2017
First Posted: March 9, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayal Aizer, Dana-Farber Cancer Institute:
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases