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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of wound infection or wound dehiscence
Secondary study objectives
Alopecia
Incidence of recovery rate
Incidence of titanium implants
+1 more
Other study objectives
Scalp thickness

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
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%
Vascular access complication
10%
Wound dehiscence
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2140

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,720 Total Patients Enrolled
Wenyin Shi, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Intensity-Modulated Stereotactic Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03251027 — N/A
Solid Tumors Research Study Groups: Treatment (IM-SRT)
Solid Tumors Clinical Trial 2023: Intensity-Modulated Stereotactic Radiation Therapy Highlights & Side Effects. Trial Name: NCT03251027 — N/A
Intensity-Modulated Stereotactic Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03251027 — N/A
~15 spots leftby Dec 2025
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