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Radiation Therapy

High-Dose Stereotactic Radiation for Brain Cancer (RAD1705 Trial)

N/A

Waitlist Available

Led By John B Fiveash, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Patients must have less than or equal to 10 brain metastases as identified on brain MRI

Must not have

History of previous whole brain irradiation

Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 years

Awards & highlights

Summary

This trial is testing if a higher dose of radiation will help people with brain metastases who have tumors measuring 2.1-4.0 cm or 4.1-6.0 cm.

Who is the study for?

This trial is for adults over 18 with a confirmed cancer diagnosis and up to 10 brain metastases, as seen on an MRI. They must have a Karnofsky performance status of at least 60, indicating they can care for themselves. Participants need to consent in writing but cannot join if they've had surgery or prior radiation on the tumor, previous whole-brain irradiation, can't undergo MRI, received certain treatments within a week before the study starts, or have another large tumor.Check my eligibility

What is being tested?

The study tests increasing doses of stereotactic radiosurgery delivered in five sessions for treating brain tumors that are between 2.1-6.0 cm in diameter. It aims to find out how much radiation can be safely given to shrink these tumors while sparing healthy tissue.See study design

What are the potential side effects?

Potential side effects may include headaches, fatigue, hair loss at treatment sites, nausea, swelling around the treated area leading to increased pressure inside the skull (which could cause various neurological symptoms), and potential damage to nearby brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have 10 or fewer brain tumors as shown on an MRI.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had whole brain radiation before.

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My second tumor is not larger than 3 cm.

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I had surgery to remove the tumor in question.

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My tumor has been treated with radiation before.

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I haven't had any cancer treatment except hormone therapy in the week before my planned radiation.

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My cancer's location prevents safe radiation treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose of five fraction stereotactic radiotherapy

Secondary outcome measures

Acute toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire

Late toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire

Rate of local tumor control with five fraction stereotactic radiotherapy using Adverse Event questionnaire

Other outcome measures

Feasibility of capturing patient reported outcomes electronically using FACT-Br Questionnaire

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalated 5 Fraction Stereotactic RadiosurgeryExperimental Treatment1 Intervention

Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 2.1-4.0cm diameter or 4.1-6.0 cm diameter. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,599 Previous Clinical Trials

2,287,907 Total Patients Enrolled

John B Fiveash, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

1 Previous Clinical Trials

26 Total Patients Enrolled

Media Library

Dose Escalated Five Fraction Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03412812 — N/A

Brain Tumor Research Study Groups: Dose Escalated 5 Fraction Stereotactic Radiosurgery

Brain Tumor Clinical Trial 2023: Dose Escalated Five Fraction Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT03412812 — N/A

Dose Escalated Five Fraction Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412812 — N/A

~2 spots leftby Jul 2025

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