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Radiation Therapy

Whole Brain vs Stereotactic Radiation for Brain Cancer

N/A

Waitlist Available

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met