Your session is about to expire
← Back to Search
Chemo-Radiation for Glioblastoma
Phase 1 & 2
Waitlist Available
Led By John Flickinger, MD
Research Sponsored by John Flickinger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4
Liver function tests and creatinine not greater than twice ULN
Must not have
Prior radiotherapy to involved site in brain.
Karnofsky Performance Status less than 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two radiation schedules with temozolomide chemo-radiotherapy for glioblastoma patients.
Who is the study for?
Adults diagnosed with WHO Grade IV Glioblastoma who can consent, have acceptable liver and kidney function tests, normal blood counts, are not pregnant or breastfeeding, and do not have distant cancer spread. Prior chemotherapy is allowed but no prior radiotherapy to the brain. Participants must be able to follow the study plan as assessed by the investigator.
What is being tested?
The trial explores two established radiation schedules for glioblastoma treatment: one delivering 40 Gy in 15 fractions and another with 25 Gy in 5 fractions. Both use concurrent temozolomide (a chemotherapy drug). Patients will be randomly assigned to either schedule to compare effectiveness.
What are the potential side effects?
Possible side effects include fatigue, skin irritation at the radiation site, nausea, headaches, hair loss from radiation therapy; temozolomide may cause nausea/vomiting, constipation/diarrhea, loss of appetite/weight changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have significant difficulty with daily activities or cannot do them at all.
Select...
My liver and kidney tests are within normal limits.
Select...
My cancer has not spread to distant parts of my body.
Select...
I am 18 or older and can sign a consent form.
Select...
My diagnosis is Grade IV Glioblastoma, confirmed before any radiotherapy.
Select...
I have received radiation treatment of 50Gy or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy on my brain before.
Select...
I need considerable assistance and medical care.
Select...
My cancer has spread to distant parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Absolute Lymphocyte Count
Overall survival (OS)
Secondary study objectives
Progression free survival (PFS) - 25 Gy in 5 fractions
Progression free survival (PFS) - 40 Gy in 15 fractions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: 40 Gy in 15 fractionsActive Control2 Interventions
Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m\^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.
Group II: 25 Gy in 5 fractionsActive Control2 Interventions
Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m\^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.
Find a Location
Who is running the clinical trial?
John FlickingerLead Sponsor
John Flickinger, MDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant difficulty with daily activities or cannot do them at all.My liver and kidney tests are within normal limits.I have had radiation therapy on my brain before.I am not pregnant, breastfeeding, and if of childbearing age, I am using effective birth control.I need considerable assistance and medical care.My cancer has not spread to distant parts of my body.I am 18 or older and can sign a consent form.My cancer has spread to distant parts of my body.My diagnosis is Grade IV Glioblastoma, confirmed before any radiotherapy.I have had a brain MRI to plan my radiotherapy.I have received radiation treatment of 50Gy or more.I have had chemotherapy before and may be on other cancer treatments as decided by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: 40 Gy in 15 fractions
- Group 2: 25 Gy in 5 fractions
Awards:
This trial has 1 awards, including:- 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.