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Radiation

Radiation Therapy for Recurrent Brain Tumors

Phase 1
Recruiting
Led By Peter GK Mathen, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 baseline through 3 years post radiation therapy.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find a safe schedule for using radiation to treat brain tumors (GBM) that have returned after initial radiation treatment. Participants in the trial will undergo re-irradiation planning where

Who is the study for?
This trial is for adults over 18 with a type of brain cancer called grade 4 glioblastoma, which has returned after initial radiation therapy. Participants must have completed their first round of treatment and be in good enough health to undergo further radiation.
What is being tested?
The study is testing different schedules of re-irradiation (radiation therapy) on patients whose glioblastoma has recurred. The goal is to find the safest way to administer this treatment by varying the frequency and duration over one, two, or three weeks.
What are the potential side effects?
Potential side effects from re-irradiation may include fatigue, skin irritation at the treatment site, headaches, nausea, hair loss around the treated area, and potential worsening of neurological symptoms due to brain swelling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 3 years post radiation therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 years post radiation therapy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MTD of daily re-irradiation in participants with recurrent grade 4 gliomas
Secondary study objectives
Compliance and feasibility of administering PRO in this participant population
Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities
Meaningful change in disease and treatment-related symptoms by using anchors
+3 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Arm 2Experimental Treatment1 Intervention
MTD of re-irradiation dose.
Group II: 1/Arm 1Experimental Treatment1 Intervention
Fraction size escalation of 3 planned re-irradiation dose levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,553 Total Patients Enrolled
Peter GK Mathen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
~19 spots leftby Dec 2027
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