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Radiation
Reduced-Dose Radiotherapy + Temozolomide for Glioblastoma
Phase 2
Recruiting
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
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
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 • NCT0304380781%
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%
hematochezia
4%
elevated ALT
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
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
620 Previous Clinical Trials
1,172,536 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself but may not be able to do active work.My steroid dose has been stable or decreasing for the last week.I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before joining.I am scheduled for a specific chemotherapy regimen.I am on dialysis or have been advised to start dialysis.My cancer tissue has been tested for MGMT promoter methylation.I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before this.I have been postmenopausal for at least one year.My diagnosis is a new case of GBM, confirmed by tissue analysis.I have recovered from major surgery to remove as much cancer as possible.I had a severe heart attack in the last 6 months.I am not pregnant or willing to use birth control during the study due to its potential risk to unborn babies.I do not have unstable chest pain.My tumor is located in the upper part of my brain.I am 18 years old or older.I have had radiation therapy to my head or neck, not for T1 glottic cancer, with overlapping treatment areas.I agree to use effective contraception or practice true abstinence during and up to four months after the study.It has been over three weeks since my brain surgery.I agree to not have sex as a form of birth control.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.My brain cancer has come back or is in multiple places.I was hospitalized for heart failure that is moderately severe or worse in the last year.My cancer has spread to distant parts of my body from the original tumor site.My recent blood test shows I have enough white blood cells, platelets, and hemoglobin.I have a condition like lupus or scleroderma that could make radiation treatment risky.I have had a recent heart attack or heart issue, shown by an EKG test.I am a woman who is either postmenopausal, surgically sterile, or using reliable birth control methods.I am a man, even if I've had a vasectomy.I am a woman.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed reduced dose-rate radiotherapy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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