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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2022 Phase 3 trial • 289 Patients • NCT0167289277%
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
13,654 Previous Clinical Trials
40,932,529 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,201 Patients Enrolled for Gliosarcoma
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,228 Total Patients Enrolled
9 Trials studying Gliosarcoma
2,915 Patients Enrolled for Gliosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but cannot do normal activities without help.I have not used Gliadel wafers or similar treatments.I haven't had serious wounds, ulcers, fractures, or major surgeries in the last 28 days.You have a very weak immune system due to a serious health condition.I am 18 years old or older.I had a brain MRI within 3 days after surgery showing a tumor or surgery area under 5 cm.My diagnosis of glioblastoma has been confirmed by a central review.My hemoglobin level is at least 10.0 g/dl, possibly after receiving treatment.My cancer has spread from its original location.I've had chemotherapy or radiosensitizers for head/neck cancer, but not for other cancers (except temozolomide).I am not on IV antibiotics for a bacterial or fungal infection.I am not pregnant and willing to use contraception if of childbearing potential.I have a serious heart rhythm problem that is not well controlled.My tumor tissue is enough for MGMT status analysis.I do not have a severe lung condition that requires hospital care right now.I can provide at least 1 block of tumor tissue for the study, preferably 2.My GBM tumor is located only in the upper part of my brain.I had a major heart attack in the last 6 months.I have liver problems causing jaundice or blood clotting issues.My diagnosis was confirmed through surgery, not just a biopsy or CUSA.I have end-stage kidney disease and need dialysis.I have records of my steroid doses from the last 28 days.I've had radiation therapy to my head or neck, not for early-stage vocal cord cancer.My tumor and the area operated on are larger than 5 cm.I have had a recent heart attack or heart strain, shown by an EKG test.I have AIDS as defined by the CDC.You have a serious health condition that is currently active and could affect your ability to participate in the study.You have a connective tissue disorder like lupus or scleroderma, which could make you more likely to experience harmful effects from radiation treatment.My brain tumor has come back or is found in multiple places.I have unstable chest pain.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.I was hospitalized for heart failure within the last year.I have recovered from surgery and its complications within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A1 (control)
- Group 2: Arm C (proton beam radiation therapy)
- Group 3: Arm A2 (control)
- Group 4: Arm B (photon IMRT)
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.
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
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