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IORT + Bevacizumab for Recurrent Glioblastoma (IORT Trial)
Phase 2
Recruiting
Led By Santosh Kesari, MD
Research Sponsored by Xoft, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
Subject must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
IORT Trial Summary
This trial is to see if a new treatment for brain cancer is better than the current standard of care.
Who is the study for?
Adults with recurrent glioblastoma who can undergo surgery, have a Karnofsky Performance Score of at least 60%, and show tumor progression on MRI. They must not have had more than three relapses, no prior VEGF/VEGFR inhibitors like Bevacizumab, and no severe co-morbidities or contraindications for MRI or anesthesia. Women must test negative for pregnancy and agree to contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of the Xoft Axxent eBx System for intra-operative radiation therapy (IORT) followed by Bevacizumab after surgical resection of recurrent glioblastoma. It aims to improve overall survival compared to historical data from previous studies using external beam radiation plus Bevacizumab.See study design
What are the potential side effects?
Possible side effects include complications from surgery, risks associated with radiation such as skin irritation or hair loss near the treated area, and those related to Bevacizumab which may include bleeding issues, high blood pressure, wound healing problems, kidney damage, and increased risk of stroke or heart problems.
IORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any conditions that cause frequent bleeding.
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I am 18 years old or older.
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My cancer has spread to new areas outside the initial treatment zone.
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My recent urine tests show normal protein levels.
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My recurrent brain tumor can fit a specific treatment device.
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My brain tumor can potentially be removed with surgery to leave less than 1 cm of the tumor.
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I am scheduled for surgery to treat my returning brain tumor.
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I am able to care for myself but may need occasional help.
IORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
median overall survival (mOS)
Secondary outcome measures
6 Month rate progression-free survival (PFS)
Local and distant progression-free survival
Quality of Life and radiation-related neurotoxicity
+2 moreOther outcome measures
imaging changes
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
IORT Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Intra-operative Radiation Therapy - IORTExperimental Treatment2 Interventions
Radiation: Intra-operative Radiation Therapy - IORT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Xoft, Inc.Lead Sponsor
10 Previous Clinical Trials
2,387 Total Patients Enrolled
Icad, Inc.Industry Sponsor
4 Previous Clinical Trials
1,248 Total Patients Enrolled
Santosh Kesari, MDPrincipal InvestigatorSaint John's Cancer Institute
2 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned in the lower part of my brain or in the lining around my brain and spinal cord.I had a major heart attack in the last 6 months.I do not have any conditions that cause frequent bleeding.My blood clotting time is stable and within the normal range on my current medication.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.I do not have a severe lung condition that requires hospital care right now.My cancer has spread to new areas outside the initial treatment zone.My recent urine tests show normal protein levels.My condition involves the optic nerve.I have been cancer-free for at least a year, except for non-dangerous skin cancers.My recurrent brain tumor can fit a specific treatment device.I haven't had non-healing wounds, ulcers, or fractures in the last 3 months.My recent MRI shows my tumor has grown.It's been over 6 months since my last radiotherapy, or I have new tumor growth outside the treated area.I have been diagnosed with GBM or a similar type of brain tumor.I agree to use birth control and not breastfeed until 6 months after my Bevacizumab treatment ends.I have not had a stroke or mini-stroke in the last 6 months.My liver and kidney tests from the last two weeks show they are working well.My hemoglobin level is at least 9.0 g/dl, possibly after receiving treatment.I have been treated with a medication that targets blood vessel growth.I have been diagnosed with AIDS according to CDC guidelines.I haven't had severe bleeding in the last 30 days.My brain tumor can potentially be removed with surgery to leave less than 1 cm of the tumor.My tumor is larger than 6 cm and has come back or not gone away.My liver and kidney tests are within normal ranges.I cannot have surgery or anesthesia due to health risks.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have received specific doses of radiation for my brain.It has been over a week since my brain biopsy.I am on full-dose anticoagulants and meet specific criteria.My urine protein levels are low enough to qualify.I am currently on IV antibiotics for a bacterial or fungal infection.I currently have a blood clot in a vein or artery.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I am scheduled for surgery to treat my returning brain tumor.My scans show true cancer growth, not just damage from radiation, and it's been over 3 months since my last radiation treatment.I have liver problems causing jaundice or blood clotting issues.My recent blood test shows normal white blood cells, platelets, and hemoglobin levels.I am on a stable dose of blood thinners without any bleeding issues.I have had more than three relapses of my condition.My condition involves the optic chiasm.My tumor is too close to vital brain areas for safe treatment.I have serious blood vessel problems.It has been over 6 months since my last radiotherapy.My cancer is present in multiple locations.I am not pregnant, nursing, and willing to use contraception if of childbearing potential.I am able to care for myself but may need occasional help.I had a blood test within the last 2 weeks showing my bone marrow works well.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Intra-operative Radiation Therapy - IORT
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.
What are the most recent findings from research involving IORT?
"There are currently 375 active clinical trials researching radiation therapy, with 99 of those trials in the third phase. While many of these trials are located in Taibei, Taiwan, there are over 18,000 locations around the world conducting studies on this topic."
Answered by AI
Are new patients currently being accepted into this trial?
"Yes, the study is currently underway and looking for 100 participants from a single site. The listing on clinicaltrials.gov shows that the trial was posted on 11/2/2021 and edited most recently on 7/14/2022."
Answered by AI
For what types of cancer is Radiation: Intra-operative Radiation Therapy - IORT most often employed?
"IORT, or Intra-operative Radiation Therapy, is a widely used radiation treatment for cancerous neoplasms. Additionally, this medical intervention can be deployed to treat other conditions like stage iv epithelial ovarian cancer, recurrent platinum sensitive primary peritoneal cancer, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
How many candidates are being enrolled in this trial?
"That is correct, the website clinicaltrials.gov has this information listed under the "study summary" for this trial. According to that data, this study was first posted on 11/2/2021 and is currently looking for 100 participants at 1 location."
Answered by AI
Does FDA approval extend to Radiation: Intra-operative Radiation Therapy - IORT?
"While there is some evidence of safety, as this is only a Phase 2 trial, more data supporting radiation: intra-operative radiation therapy - IORT's efficacy needs to be gathered. Consequently, it receives a score of 2."
Answered by AI
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