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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 belowSelect...
I have brain tumors confirmed by imaging tests.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreOther outcome measures
Exploratory: Correlation of RNA biomarkers
Side effects data
From 2023 Phase 1 trial • 35 Patients • NCT0094452881%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for targeted brain radiation therapy after my main treatment.A neurosurgeon has determined I cannot have surgery.I have brain tumors confirmed by imaging tests.A neurosurgeon has approved me for surgery to remove at least one cancer spread.I am currently on chemotherapy or immunotherapy, but not on anti-VEGF therapy.My brain scan shows 1-4 solid tumor metastases, with the largest no bigger than 5 cm.My neurosurgeon agrees I can undergo surgery.I can have surgery 1-4 days after my radiosurgery.My radiation oncologist says I'm a candidate for precise radiation therapy.I have not taken anti-VEGF therapy in the last 6 weeks.The area of my cancer to be removed is larger than 5 cm.My cancer has spread to the lining of my brain or spinal cord.I have had whole brain radiation therapy before.I am 18 years old or older.The lesion to be removed has been treated with radiation before.My cancer spread is larger than 30 cm3, not counting the part to be removed.My doctor has decided I cannot have radiosurgery.My surgery is not scheduled within 1-4 days after my radiosurgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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.
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."
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