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Radiation Therapy

Whole Brain vs Stereotactic Radiation for Brain Cancer

Q: What are the requirements to enroll in this program?

<p>This study is looking for 196 individuals that have <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, are aged 18-80, and have a second primary.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Life Survey (symptoms and interference)

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,790 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,614 Previous Clinical Trials

11,470,639 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will elderly patients be included in this clinical research?

"The age range this clinical trial is targeting are individuals that are 18 and up, but no older than 80 years old."

Answered by AI

Does Stereotactic radiation (SRS) have FDA approval?

"There is evidence from past clinical trials to support the efficacy of SRS, resulting in a safety score of 3."

Answered by AI

Have recruitment efforts begun for this research project?

"That is correct, the information available on clinicaltrials.gov says that this trial is open and recruiting patients. This specific study was first advertised on April 10th, 2017 with a most recent update being July 18th, 2022. They are looking for 196 people to participate at 2 different locations."

Answered by AI