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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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

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
64,303 Total Patients Enrolled
8 Trials studying Gliosarcoma
3,249 Patients Enrolled for Gliosarcoma
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,105 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,195 Patients Enrolled for Gliosarcoma
NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,155 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this research project?

"Unfortunately, this specific clinical trial is no longer recruiting patients. Although, there are 459 other studies currently underway for adult giant cell glioblastoma and 218 trials concerning intensity-modulated radiation therapy that could use your help."

Answered by AI

What sorts of cancer does intensity-modulated radiation therapy help manage?

"Intensity-modulated radiation therapy can be used to not only treat nitrosourea treatment, but also other conditions such as advance directives, refractory, advanced mycosis fungoides, and refractory neuroblastoma."

Answered by AI

Is this ongoing research project being conducted at different hospitals around the US?

"You can find a comprehensive list of the 47 participating medical centres on the study website, but a few notable locations include: Massachusetts General Hospital Cancer Center in Boston, CHUM - Hopital Notre-Dame in Montreal, and WellSpan Health-York Cancer Center in York."

Answered by AI

Does this type of research project break new ground?

"There are 218 ongoing trials for intensity-modulated radiation therapy in 947 cities across 36 countries. The first study was conducted in 2002 and completed Phase 2 drug approval with 60 patients. 1112 studies have been completed since then."

Answered by AI

Can you please provide more information about other similar research studies that have used intensity-modulated radiation therapy?

"According to clinicaltrials.gov, the first study into intensity-modulated radiation therapy was conducted in 2002 at Memorial Sloan Kettering Cancer Center. Since then, there have been a further 1112 completed studies with 218 currently recruiting patients. A large proportion of these are based in Boston, Massachusetts."

Answered by AI

Could you please describe the risks associated with intensity-modulated radiation therapy?

"While there is some evidence that intensity-modulated radiation therapy is safe, it only received a 2 because there are no studies yet demonstrating its efficacy."

Answered by AI

How large is the scale of this clinical trial?

"This specific study is no longer recruiting patients, having last done so on May 18th, 2022. However, as of right now there are 459 other trials involving adult giant cell glioblastoma and 218intensity-modulated radiation therapy that are actively looking for patients to enroll."

Answered by AI
~59 spots leftby May 2025