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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights
RAD1705 Trial 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.
RAD1705 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have 10 or fewer brain tumors as shown on an MRI.
Select...
I can care for myself but may need occasional help.
RAD1705 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
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
RAD1705 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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,299 Total Patients Enrolled
John B Fiveash, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had whole brain radiation before.My second tumor is not larger than 3 cm.My tumor has been treated with radiation before.I am older than 18 years.I had surgery to remove the tumor in question.I haven't had any cancer treatment except hormone therapy in the week before my planned radiation.My cancer's location prevents safe radiation treatment.I have 10 or fewer brain tumors as shown on an MRI.I can care for myself but may need occasional help.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalated 5 Fraction Stereotactic Radiosurgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a current call for volunteers to participate in this medical experiment?
"As indicated on clinicaltrials.gov, this research endeavour is currently recruiting participants. It was initially published on July 30th 2018 and recently updated on March 25th 2022."
Answered by AI
How many individuals are currently participating in this research investigation?
"Affirmative. Clinicaltrials.gov's records demonstrate that this study, which was initially published on July 30th 2018, is still open for recruitment. Approximately 60 participants are required from a single trial site."
Answered by AI
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