← Back to Search

Radiation Therapy

High-Dose Radiation + Temozolomide for Glioblastoma

Phase 2
Waitlist Available
Led By Minesh Mehta
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status >= 70 within 28 days prior to step 2 registration
Age >= 18
Must not have
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying how well two types of radiation therapy work compared to standard radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.

Who is the study for?
Adults with newly diagnosed glioblastoma located in the supratentorial compartment, who have undergone surgery and are able to undergo MRI scans. Participants must not have had prior invasive malignancies (except certain skin cancers) within 3 years or any previous chemotherapy for head and neck cancer (excluding temozolomide). They should be free from serious medical conditions that could interfere with the trial, not pregnant, willing to use contraception, and without a history of HIV/AIDS.Check my eligibility
What is being tested?
The study is testing if higher doses of photon IMRT or proton beam radiation therapy can be more effective than standard-dose radiation when combined with temozolomide in treating glioblastoma. The goal is to see if these intensified treatments better target tumors while sparing healthy tissue and enhancing sensitivity to medication.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with radiation therapy such as fatigue, skin irritation at the treatment site, hair loss, headache, nausea; and those related to temozolomide like low blood counts leading to increased infection risk, nausea/vomiting, constipation/diarrhea, loss of appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can care for myself but cannot do normal activities without help.
Select...
I am 18 years old or older.
Select...
I had a brain MRI within 3 days after surgery showing a tumor or surgery area under 5 cm.
Select...
My diagnosis of glioblastoma has been confirmed by a central review.
Select...
My tumor tissue is enough for MGMT status analysis.
Select...
I can provide at least 1 block of tumor tissue for the study, preferably 2.
Select...
My GBM tumor is located only in the upper part of my brain.
Select...
My diagnosis was confirmed through surgery, not just a biopsy or CUSA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on IV antibiotics for a bacterial or fungal infection.
Select...
I am not pregnant and willing to use contraception if of childbearing potential.
Select...
I have not used Gliadel wafers or similar treatments.
Select...
I have a serious heart rhythm problem that is not well controlled.
Select...
My cancer has spread from its original location.
Select...
I do not have a severe lung condition that requires hospital care right now.
Select...
I have end-stage kidney disease and need dialysis.
Select...
I've had radiation therapy to my head or neck, not for early-stage vocal cord cancer.
Select...
My tumor and the area operated on are larger than 5 cm.
Select...
My brain tumor has come back or is found in multiple places.
Select...
I have unstable chest pain.
Select...
I was hospitalized for heart failure within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absorptiometry, Photon
Secondary outcome measures
Change in CD4 lymphopenia count
Change in neurocognitive function, as measured by Hopkins' Verbal Learning Test-Revised, Trail Making Test Parts A and B, and Controlled Oral Word Association Test
Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor
+4 more

Side effects data

From 2022 Phase 3 trial • 289 Patients • NCT01672892
77%
Diarrhea
73%
Fatigue
39%
Nausea
37%
Abdominal pain
30%
Urinary frequency
21%
Anemia
21%
Constipation
21%
Anorexia
18%
Urinary incontinence
18%
Pelvic pain
17%
White blood cell decreased
16%
Edema limbs
16%
Pain
13%
Dyspnea
13%
Vomiting
13%
Headache
12%
Paresthesia
11%
Lymphocyte count decreased
10%
Bloating
10%
Hypomagnesemia
10%
Urinary tract pain
10%
Urinary urgency
10%
Urinary tract infection
10%
Cough
10%
Hot flashes
10%
Insomnia
9%
Platelet count decreased
9%
Rectal pain
8%
Gastrointestinal disorders - Other
8%
Proctitis
8%
Hyperglycemia
8%
Hyponatremia
8%
Anxiety
8%
Renal and urinary disorders - Other
8%
Weight loss
7%
Depression
7%
Cystitis noninfective
7%
Alopecia
6%
Tinnitus
6%
Blurred vision
6%
Neutrophil count decreased
6%
Hypokalemia
6%
Back pain
6%
Generalized muscle weakness
6%
Peripheral sensory neuropathy
6%
Vaginal discharge
6%
Vaginal hemorrhage
6%
Pruritus
6%
Hypertension
6%
Dermatitis radiation
6%
Dyspepsia
6%
Hypoalbuminemia
4%
Rectal hemorrhage
3%
Vaginal stricture
3%
Arthralgia
2%
Skin and subcutaneous tissue disorders - Other
1%
Device related infection
1%
Vaginal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensity-Modulated Radiation Therapy
Standard Radiation Therapy

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (proton beam radiation therapy)Experimental Treatment3 Interventions
Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (photon IMRT)Experimental Treatment4 Interventions
Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm A1 (control)Active Control4 Interventions
Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Group IV: Arm A2 (control)Active Control4 Interventions
Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
proton beam radiation therapy
2010
Completed Phase 2
~90
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
temozolomide
2008
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,302 Total Patients Enrolled
8 Trials studying Gliosarcoma
3,249 Patients Enrolled for Gliosarcoma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,777 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,210 Patients Enrolled for Gliosarcoma
NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,125 Total Patients Enrolled
9 Trials studying Gliosarcoma
2,927 Patients Enrolled for Gliosarcoma

Media Library

Photon Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02179086 — Phase 2
Gliosarcoma Research Study Groups: Arm A1 (control), Arm C (proton beam radiation therapy), Arm A2 (control), Arm B (photon IMRT)
Gliosarcoma Clinical Trial 2023: Photon Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02179086 — Phase 2
Photon Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02179086 — Phase 2
~58 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top