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Radiation

Reduced-Dose Radiotherapy + Temozolomide for Glioblastoma

Phase 2
Waitlist Available
Led By Michael Straza, MD, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status Scale ≥ 70.
Planned for standard adjuvant chemoradiotherapy of approximately 60 Gy of radiation therapy (RT) , or biologically equivalent dose, according to local practice, and concomitant TMZ chemotherapy (75 mg/m^2 daily). Any other cytotoxic or biologic antitumor therapy received prior to enrollment will be considered an exclusion.
Must not have
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing whether a lower dose of radiation therapy is just as effective as the standard dose in treating glioblastoma.

Who is the study for?
Adults diagnosed with new glioblastoma who've had surgery, if needed, and are set for standard chemo-radiotherapy. They should have a life expectancy of over three months, stable health without severe illnesses or prior invasive cancers (except certain skin cancers), and agree to contraception if applicable. Patients can't join if they have recurrent brain tumors, other cancer sites, recent heart issues, connective tissue diseases at high risk for radiation toxicity, kidney failure requiring dialysis, or pregnancy.
What is being tested?
The trial is testing pulsed reduced dose radiotherapy (pRDR) as an alternative to standard radiation therapy in combination with Temozolomide chemotherapy for the initial treatment of glioblastoma. The goal is to see how this approach affects disease progression compared to the current standard treatment.
What are the potential side effects?
Potential side effects include those common to radiation therapy such as fatigue, hair loss at the treated site, headaches and nausea; and those related to Temozolomide like tiredness, constipation or diarrhea, loss of appetite and risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before joining.
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I am scheduled for a specific chemotherapy regimen.
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I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before this.
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I have been postmenopausal for at least one year.
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My diagnosis is a new case of GBM, confirmed by tissue analysis.
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My tumor is located in the upper part of my brain.
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It has been over three weeks since my brain surgery.
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My recent blood test shows I have enough white blood cells, platelets, and hemoglobin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or willing to use birth control during the study due to its potential risk to unborn babies.
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I am on dialysis or have been advised to start dialysis.
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I do not have unstable chest pain.
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I have had radiation therapy to my head or neck, not for T1 glottic cancer, with overlapping treatment areas.
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I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.
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My brain cancer has come back or is in multiple places.
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My cancer has spread to distant parts of my body from the original tumor site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Death
Progression-free survival

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807
81%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
elevated ALT
4%
hematochezia
4%
cough
4%
elevated AST
4%
xerostomia
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Pulsed reduced dose-rate radiotherapyExperimental Treatment3 Interventions
Chemoradiation, adjuvant chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,920 Total Patients Enrolled
3 Trials studying Glioblastoma
116 Patients Enrolled for Glioblastoma
Michael Straza, MD, PhDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin

Media Library

pulsed reduced dose radiotherapy (pRDR) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04747145 — Phase 2
Glioblastoma Research Study Groups: Pulsed reduced dose-rate radiotherapy
Glioblastoma Clinical Trial 2023: pulsed reduced dose radiotherapy (pRDR) Highlights & Side Effects. Trial Name: NCT04747145 — Phase 2
pulsed reduced dose radiotherapy (pRDR) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747145 — Phase 2
~3 spots leftby Mar 2025
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