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Radiation

1/Arm 1 for Brain Tumor

Phase 1

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 3 years post radiation therapy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MTD of daily re-irradiation in participants with recurrent grade 4 gliomas

Secondary outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,344 Total Patients Enrolled

Peter GK Mathen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 40 years eligible to participate in this research study?

"This research trial specifies that individuals between the ages of 18 and 120 are eligible to participate. In contrast, there are currently 260 trials targeting participants under 18 years old and 1415 studies focusing on those above 65 years old."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"According to the details on clinicaltrials.gov, patient recruitment for this research is closed. The trial was initially listed on 4/8/2024 and updated last on 4/2/2024. However, there are currently 1625 other trials actively seeking participants at present."

Answered by AI

Has the first arm of the study been given approval by the Food and Drug Administration (FDA)?

"The safety rating for Arm 1 is set at level 1 as per our assessment, aligning with it being a Phase 1 trial where there exists only preliminary data regarding both the safety and efficacy of the intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

2024. "Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06344130.

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