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MR-Guided Adaptive Radiotherapy + Temozolomide for Glioblastoma

Phase 2
Recruiting
Led By Michelle Kim, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow reserve (Hemoglobin ≥ 10 g/dL, absolute neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3), acceptable liver function (total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), and ALT/AST ≤ 5 x ULN) and renal function (serum creatinine ≤ 2.0 mg/dL) within 14 day prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment and study participation.
Must not have
Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap as determined by treating physician
Multifocal disease (>1 lobe of involvement) of discontiguous contrast enhancing disease as seen on conventional MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new radiation therapy method can help people with glioblastoma live longer.

Who is the study for?
This trial is for adults with newly diagnosed glioblastoma who can give informed consent, follow study procedures, and have a life expectancy of at least 12 weeks. They should be in good physical condition (Karnofsky score ≥70), have adequate organ function, and agree to use contraception if applicable. The tumor must be ≤5 cm in diameter and patients must enroll within 6 weeks post-surgery.
What is being tested?
The study tests if intensified radiation therapy targeted at high-risk tumor areas during treatment improves survival in glioblastoma patients compared to standard chemoradiotherapy. It includes dose-intensified radiotherapy with concurrent temozolomide followed by adjuvant temozolomide.
What are the potential side effects?
Potential side effects include fatigue, skin irritation at the radiation site, nausea, low blood counts leading to increased infection risk or bleeding problems, liver and kidney function changes, headaches, hair loss around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, liver, and kidney functions meet the required levels for the trial.
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I am not pregnant and agree to use birth control during the study.
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My tumor is 5 cm or smaller on a specific MRI scan.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy on my head or neck that overlaps with current treatment areas.
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My MRI shows cancer in more than one part of an organ.
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My tests show cancer cells in my spinal fluid or MRI signs of cancer spread in spinal fluid.
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I cannot have an MRI due to a pacemaker or metal implants.
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My cancer has returned or is in my brainstem or cerebellum.
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I have a serious health condition that needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
12-month overall survival rate
Secondary study objectives
Advanced MRI Gross tumor volume (GTV) and its association with overall survival
Grade 3 or higher treatment-related toxicities
Overall survival
+5 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: Patients with Newly Diagnosed GlioblastomaExperimental Treatment3 Interventions
Patients will receive dose-intensified, adaptive photon radiation therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,205 Total Patients Enrolled
4 Trials studying Glioblastoma
119 Patients Enrolled for Glioblastoma
Michelle Kim, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

Dose-Intensified Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04574856 — Phase 2
Glioblastoma Research Study Groups: Patients with Newly Diagnosed Glioblastoma
Glioblastoma Clinical Trial 2023: Dose-Intensified Radiotherapy Highlights & Side Effects. Trial Name: NCT04574856 — Phase 2
Dose-Intensified Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574856 — Phase 2
~1 spots leftby Feb 2025
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