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Radiation Therapy

Whole Brain vs Stereotactic Radiation for Brain Cancer

N/A
Recruiting
Led By Ayal Aizer, MD MHS
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status of at least 70
Participants must have a biopsy proven solid malignancy with untreated intracranial lesions radiographically consistent with or pathologically proven to be brain metastases
Must not have
Participants who have undergone prior radiation for brain metastases
Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is studying two types of radiation to treat brain metastases.

Who is the study for?
This trial is for adults aged 18-80 with solid tumors that have spread to the brain, showing 5-20 metastases on MRI. They must be in good physical condition (Karnofsky score ≥70) and can have had previous systemic therapy. Excluded are those who've had brain radiation before, cannot get an MRI or gadolinium contrast, have severe kidney disease, certain cancers like small cell lung cancer, lymphoma or myeloma, or a very large tumor over 5 cm.
What is being tested?
The study compares two radiation treatments for patients with multiple brain tumors from another cancer source: whole-brain radiation versus stereotactic radiation (SRS), which targets specific areas. It's designed to see which method is more effective at treating these types of brain metastases.
What are the potential side effects?
Potential side effects include fatigue, hair loss around treated areas, headaches, nausea and memory problems due to whole-brain radiation; SRS may cause similar issues but localized to the targeted regions. Both methods carry risks of tissue damage leading to symptoms related to affected brain functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but cannot do normal activities without help.
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I have a confirmed solid tumor with untreated brain metastases.
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I was between 18 and 80 years old when my brain cancer was diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation treatment for cancer that spread to my brain.
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My tumor is larger than 5 cm and has not been removed.
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I cannot receive MRI contrast.
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My cancer has spread to the lining of my brain and spinal cord.
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My kidney disease is in stage IV-V or I have end-stage renal disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Life Survey (symptoms and interference)
Secondary study objectives
Incidence and time to additional radiotherapeutic treatments
Incidence and time to detection of new brain metastases
Incidence and time to development of leptomeningeal disease
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Radiation (SRS)Experimental Treatment1 Intervention
* 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)
Group II: Whole Brain RadiationActive Control1 Intervention
* 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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
352,901 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,653 Previous Clinical Trials
11,490,839 Total Patients Enrolled
Ayal Aizer, MD MHSPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute
Yale University School Of Medicine (Medical School)
~0 spots leftby Sep 2024