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Radiation Therapy
Intensity-Modulated Radiation Therapy for Brain Tumor
N/A
Recruiting
Led By Wenyin Shi, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing how well a specialized radiation therapy works in treating patients with brain tumors. This therapy delivers a high dose of radiation directly to the tumor.
Who is the study for?
This trial is for patients with grade II-IV glioma who have a Karnofsky performance status of 60 or above, meaning they can care for themselves but may not be able to carry out normal activity or do active work. They must have recovered from surgery at least 21 days prior and begin radiation treatment within 3-8 weeks after surgery. Patients with diabetes requiring insulin, current smokers, previous scalp radiation, intolerance to standard radiation, pregnancy, or inability to use contraception are excluded.Check my eligibility
What is being tested?
The trial is testing intensity-modulated stereotactic radiation therapy on patients with low to high-grade gliomas (brain tumors). This advanced form of targeted radiotherapy aims to deliver a high dose directly to the tumor while minimizing damage to surrounding healthy tissue.See study design
What are the potential side effects?
Potential side effects include localized skin reactions like redness and irritation where the radiation is delivered. There might also be fatigue, headaches due to swelling in the brain from the targeted therapy, and temporary hair loss around treated areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of wound infection or wound dehiscence
Secondary outcome measures
Alopecia
Incidence of recovery rate
Incidence of titanium implants
+1 moreOther outcome measures
Scalp thickness
Side effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Wound dehiscence
10%
Vascular access complication
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (IM-SRT)Experimental Treatment2 Interventions
Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,786 Total Patients Enrolled
2 Trials studying Glioblastoma
47 Patients Enrolled for Glioblastoma
Wenyin Shi, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Glioblastoma
30 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor believes you have at least three more months to live.You cannot have an MRI scan.You currently have a medical condition named collagen vascular disease that is actively causing problems.You have diabetes that requires insulin or you are currently a smoker, which could affect how well your wounds heal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (IM-SRT)
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 we still able to sign new patients up for the research?
"The correct. According to the information available on clinicaltrials.gov, this study is still recruiting patients. This trial was initially posted on July 17th, 2017 and was last updated September 7th, 2020. The study is looking for 125 individuals from 1 site."
Answered by AI
Could you please outline the risks associated with Intensity-Modulated Radiation Therapy?
"Intensity-Modulated Radiation Therapy is thought to be safe based on Phase 2 trial data, but more research is needed to support its efficacy."
Answered by AI
How many people can be enrolled in this research project?
"Yes, the information on clinicaltrials.gov indicates that this clinical trial is currently looking for participants. The study was first posted on 7/17/2017 and was last edited on 9/7/2022. The trial is admitting 125 patients at 1 locations."
Answered by AI
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