Phase 2
N=90
Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)
Brain Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01854554 ↗Enrolled (actual)
90
Serious AEs
4.5%
Results posted
Jan 2024
Primary outcome: Primary: Time to Cognitive Failure — 7.7; 4.9 months — p=.74
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMPT (Radiation); IMRT (Radiation); Cognitive Tests (Behavioral); Questionnaires (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cognitive Failure |
7.7; 4.9 | .74 |
| SECONDARY Overall Survival |
21.2; 24.5 | .60 |
| SECONDARY Progression Free Survival (PFS) |
8.9; 6.6 | 0.24 |
| SECONDARY Number of Participants Experienced Adverse Events by Maximum Grade (Grade 2 or Higher) |
2; 1; 4; 2; 14; 5 | — |
Summary
The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.
IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues.
IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.
Eligibility Criteria
Inclusion Criteria
- Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
- All patients must be >/=18 years of age.
- All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is the one approved by MD Anderson IRB.
- All patients must have a baseline Mini Mental Status Examination score >/=21.
- All patients must have a KPS >/=70.
- All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
- All patients must be able to undergo MRI with and without contrast with a glomerular filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m2.
- All patients must have adequate liver, renal, and hematologic function within 14 days of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase /=1,800 cells/mm3, Hemoglobin >/= 10 g/dl, and platelet count > 100,000.
- All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments. However mild to moderate deficits in these functions due to tumor are allowed.
Exclusion Criteria
- Patients will be excluded if they are not planning to receive concurrent temozolomide.
- Patients will be excluded if they have had prior radiation to the brain.
- Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
- Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential.
- Patients with gliomatosis will be excluded.
- Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
- Patients weighing greater than 136 kilograms will be excluded.
Data sourced from ClinicalTrials.gov (NCT01854554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.