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Radiation Therapy

Radiosurgery Before Surgery for Brain Cancer

N/A
Waitlist Available
Led By Namita Agrawal, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiographically confirmed solid tumor brain metastases
≥ 18 years old at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new way to treat brain cancer that involves surgery after radiation. The aim is to see if this new method increases the local control of the cancer at six months.

Who is the study for?
This trial is for adults with 1-4 confirmed brain metastases from solid tumors, who are candidates for surgical removal of at least one tumor. They must have a life expectancy of at least 6 months and be able to understand the study details and consent. Excluded are those with more than 4 brain metastases, previous whole-brain radiation, or certain medical conditions that could interfere with treatment.Check my eligibility
What is being tested?
The trial tests pre-operative stereotactic radiosurgery followed by surgery within 1-4 days on patients with brain metastases. The goal is to determine how well this approach controls the disease six months after treatment.See study design
What are the potential side effects?
Potential side effects include typical risks associated with radiosurgery such as headaches, swelling, bleeding in the brain or fatigue; and surgical risks like infection, bleeding during surgery or neurological damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have brain tumors confirmed by imaging tests.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Rate of local control of any new, recurrent, or progressing tumors within the planning target volume
Secondary outcome measures
Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)
Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)
Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)
+2 more
Other outcome measures
Exploratory: Correlation of RNA biomarkers

Side effects data

From 2023 Phase 1 trial • 35 Patients • NCT00944528
81%
Fibrosis deep connective tissue
56%
Dermatitis radiation
50%
Breast pain
50%
Seroma
31%
Skin induration
25%
Skin hyperpigmentation
25%
Skin ulceration
19%
Breast atrophy
13%
Superficial soft tissue fibrosis
13%
Fatigue
13%
Skin and subcutaneous tissue disorders - Other
6%
Pruritus
6%
Chest pain -cardiac
6%
Infections and infestations-Other
6%
Telangiectasia
6%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Dose Radiosurgery: Dose Level 3
Single Dose Radiosurgery: Dose Level 1
Single Dose Radiosurgery: Dose Level 2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiosurgery
2005
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,327 Total Patients Enrolled
Namita Agrawal, MDPrincipal Investigator - Indiana University School of Medicine
Indiana University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03398694 — N/A
Brain Tumor Research Study Groups: Arm 1
Brain Tumor Clinical Trial 2023: Radiosurgery Highlights & Side Effects. Trial Name: NCT03398694 — N/A
Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03398694 — N/A

Frequently Asked Questions

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

Are there openings for enrollment into the experiment at this time?

"This investigation, which was originally advertised on May 1st 2018 and last amended on June 8th 2022, is not actively recruiting participants. Nevertheless, there are a plethora of other clinical trials that require enrolment at the current moment in time."

Answered by AI
Recent research and studies
~7 spots leftby Mar 2025