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

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.
 
ClinicalTrials.gov Identifier: NCT03075072
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : September 25, 2023
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ayal Aizer, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date September 25, 2023
Actual Study Start Date  ICMJE April 10, 2017
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2020)		 Quality of Life Survey (symptoms and interference) [ Time Frame: 6 months ]
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2017)		 Quality of Life [ Time Frame: 6 months ]
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • 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 5-20 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2017)
  • 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
  • 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
  • Incidence and time to neurocognitive decline [ Time Frame: 1 year ]
    Clinical assessment of neurocognitive decline
  • Performance status [ Time Frame: Through study completion, an average of 1 year ]
    Questionnaire - Karnofsky performance status
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
Official Title  ICMJE Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE
  • Radiation: Whole brain radiation
    Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
  • Radiation: Stereotactic radiation (SRS)
    Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.
Study Arms  ICMJE
  • 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
    Intervention: Radiation: Whole brain 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)
    Intervention: Radiation: Stereotactic radiation (SRS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2017)		 196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ayal Aizer, MD 617-732-7560 aaaizer@partners.org
Contact: Ivy Ricca, BA 6175828927 iricca@mgb.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075072
Other Study ID Numbers  ICMJE 16-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ayal Aizer, MD, Dana-Farber Cancer Institute
Original Responsible Party Ayal Aizer, Dana-Farber Cancer Institute, Principal Investigator
Current Study Sponsor  ICMJE Dana-Farber Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Ayal Aizer, MD MHS Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP