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.
Eligible Conditions
- Glioblastoma
- Adult Giant Cell Glioblastoma
- Gliosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 5 years
Year 5
Change in CD4 lymphopenia count
Week 60
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
Year 5
Absorptiometry, Photon
Year 5
OS when compared between dose-escalated and -intensified photon IMRT to dose-escalated and -intensified proton beam therapy
Year 5
Progression-free survival (PFS)
Up to 5 years
Incidence of treatment-related toxicity, as measured by the Common Terminology Criteria for Adverse Events version 4
Use of magnetic resonance diffusion and perfusion imaging to differentiate between tumor progression and pseudo-progression
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Standard Radiation Therapy
78%Diarrhea
65%Fatigue
43%Nausea
40%Abdominal pain
33%Urinary frequency
21%Pelvic pain
19%Vomiting
19%Anorexia
18%Constipation
17%Urinary urgency
15%Urinary incontinence
15%Urinary tract pain
14%Pain
13%Insomnia
12%Anemia
12%Lymphocyte count decreased
12%Edema limbs
11%White blood cell decreased
11%Hyperglycemia
11%Dermatitis radiation
10%Back pain
10%Tinnitus
10%Skin and subcutaneous tissue disorders - Other
10%Headache
10%Dyspnea
9%Rectal pain
9%Bloating
9%Peripheral sensory neuropathy
8%Depression
8%Vaginal discharge
8%Paresthesia
8%Alopecia
8%Hot flashes
8%Cough
8%Anxiety
7%Gastrointestinal disorders - Other
7%Urinary tract infection
7%Rectal hemorrhage
7%Cystitis noninfective
7%Pruritus
6%Weight loss
6%Hypertension
6%Renal and urinary disorders - Other
6%Arthralgia
6%Vaginal pain
6%Proctitis
6%Neutrophil count decreased
6%Dyspepsia
6%Vaginal stricture
6%Generalized muscle weakness
5%Hyponatremia
4%Platelet count decreased
3%Hypokalemia
3%Blurred vision
3%Hypomagnesemia
3%Vaginal hemorrhage
1%Hypoalbuminemia
Trial Design
4 Treatment Groups
Arm A1 (control)
1 of 4
Arm A2 (control)
1 of 4
Arm C (proton beam radiation therapy)
1 of 4
Arm B (photon IMRT)
1 of 4
Active Control
Experimental Treatment
624 Total Participants · 4 Treatment Groups
Primary Treatment: intensity-modulated radiation therapy · No Placebo Group · Phase 2
Arm C (proton beam radiation therapy)Experimental Group · 3 Interventions: temozolomide, proton beam radiation therapy, laboratory biomarker analysis · Intervention Types: Drug, Radiation, Other
Arm B (photon IMRT)Experimental Group · 4 Interventions: intensity-modulated radiation therapy, temozolomide, photon beam radiation therapy, laboratory biomarker analysis · Intervention Types: Radiation, Drug, Radiation, Other
Arm A1 (control)ActiveComparator Group · 4 Interventions: intensity-modulated radiation therapy, 3-dimensional conformal radiation therapy, temozolomide, laboratory biomarker analysis · Intervention Types: Radiation, Radiation, Drug, Other
Arm A2 (control)ActiveComparator Group · 4 Interventions: intensity-modulated radiation therapy, 3-dimensional conformal radiation therapy, temozolomide, laboratory biomarker analysis · Intervention Types: Radiation, Radiation, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intensity-modulated radiation therapy
2008
Completed Phase 3
~1500
Temozolomide
FDA approved
proton beam radiation therapy
2010
Completed Phase 2
~90
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,267 Total Patients Enrolled
19 Trials studying Glioblastoma
6,330 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,128,678 Total Patients Enrolled
303 Trials studying Glioblastoma
21,891 Patients Enrolled for Glioblastoma
NRG OncologyLead Sponsor
217 Previous Clinical Trials
93,504 Total Patients Enrolled
13 Trials studying Glioblastoma
3,842 Patients Enrolled for Glioblastoma
Minesh Mehta, MDPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
270 Total Patients Enrolled
Minesh MehtaPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
24 Total Patients Enrolled
Vinai Gondi, MDPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
310 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:To be eligible for the study, patients must submit at least 1 block of tumor tissue
The patient has a histologically proven diagnosis of glioblastoma (WHO grade IV) that has been confirmed by a central review
will be collected and snap frozen
Tumor tissue that is found to have enough quantity for analysis of O6-methylguanin-DNA-methyltransferase (MGMT) status will be collected and frozen.
Within 28 days prior to step 2 registration, the individual must have a history/physical examination.
Prior to Step 1 Registration, you will need to complete the following:
1
A contrast-enhanced MRI of the brain must be performed postoperatively within 72 hours of surgery; if the tumor is 5 cm or less in diameter, the patient is eligible for the trial.
The GBM tumor must be located in the top part of the brain only
and prior to any study-related procedures
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Conditions
Cancer Related
Treatments