← Back to Search

Radiation Therapy

MRI-Guided Radiation for Glioblastoma

Phase 2

Waitlist Available

Led By Hui-Kuo Shu, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist

Patients must have a Karnofsky performance status (KPS) ≥ 60

Must not have

Patients with an active infection or serious intercurrent medical illness are ineligible

Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give radiation therapy for brain tumors, using MRI to better target the tumor. The goal is to see if this new method is more effective and has fewer side effects than the current standard of care.

Who is the study for?

This trial is for patients with newly-diagnosed glioblastoma or gliosarcoma who can undergo MRI scans, have not received prior brain tumor treatments, and do not have certain medical implants that affect MRI safety. They should be in a condition to forego other cancer therapies during the trial, have specific blood counts and organ function levels within set ranges, expect to live at least 12 weeks, and be able to swallow capsules.

What is being tested?

The study tests spectroscopic MRI-guided radiation therapy combined with Temozolomide chemotherapy in treating brain tumors. Spectroscopic MRI aims to better identify tumor metabolism beyond what standard MRIs show. The goal is to see if this leads to more effective radiation treatment by targeting the tumors more precisely.

What are the potential side effects?

Potential side effects may include typical reactions from radiation therapy such as fatigue, skin irritation at the treatment site, headaches, nausea, hair loss near treated areas; and from Temozolomide like low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor is newly diagnosed and confirmed as glioblastoma or gliosarcoma.

Select...

I am mostly able to care for myself but may need occasional help.

Select...

I can swallow pills.

Select...

I agree not to take other cancer treatments while on this trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any active infections or serious illnesses.

Select...

I have not taken any drugs for a brain tumor before.

Select...

I have never had radiation therapy to my head.

Select...

I am not currently participating in another cancer treatment trial.

Select...

My tumor is smaller than 65 cubic centimeters.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility as assessed by successful co-registration of sMRI-based treatment volumes with clinical images into the radiation treatment execution platform

Incidence of adverse event assessed by Common Terminology Criteria for Adverse Events version 4.0

Secondary study objectives

Progression free survival (PFS)

Other study objectives

Early evidence of GBM progression assessed by sMRI

Neurocognitive performance: Controlled Oral Word Association Test

Neurocognitive performance: Hopkins Verbal Learning Test

+3 more

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: sMRI-Guided RT with TMZExperimental Treatment3 Interventions

Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

0 / 9Eligibility criteria met