Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma

Running, not enrolling · Phase 2

Conditions studied: Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma, Glioma, Oligoastrocytoma, Oligodendroglioma, WHO Grade 3 Glioma

In brief

This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

Key facts

Study ID

NCT03180502

Run by

NRG Oncology

People needed

120

Starts

2018-01-23

Expected to finish

2031-07-13

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PRIOR TO STEP 1 REGISTRATION
• Tumor tissue must be available for submission for central pathology review
• Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
• Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories and be uploaded prior to Step 2 registration
• Age >= 18
• The trial is open to both genders
• Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
• History and physical exam, and Karnofsky performance status of >= 70 within 30 days prior to registration
• Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 (within 60 days prior to registration)
• Platelets >= 100,000 cells/mm\^3 (within 60 days prior to registration)
• Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (within 60 days prior to registration)
• Bilirubin =< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 60 days prior to registration)
• Blood urea nitrogen (BUN) < 30 mg/dl (within 60 days prior to registration)
• Serum creatinine < 1.5 mg/dl (within 60 days prior to registration)
• Pre-operative MRI imaging of the brain available for radiation planning
• Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are not mandated although highly encouraged to obtain thin-slice (< 1.5 mm) 3 dimensional (D) pre and post contrast and axial T2/FLAIR sequences for planning purposes
• Patients must be able to swallow capsules
• PRIOR TO STEP 2 REGISTRATION
• Histologically proven diagnosis of supratentorial, World Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation confirmed by central review
• The following baseline neurocognitive assessments must be completed and uploaded prior to Step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT Parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidata RAVE System for central evaluation; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the Research Associate (RA) to proceed to Step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors)
• Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration
• Financial clearance for proton therapy treatment prior step 2 registration
• Women of childbearing age must have a negative serum pregnancy test within 14 days prior to step 2 registration

You may not qualify if…

• Definitive clinical or radiologic evidence of metastatic disease; if applicable
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
• Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
• Prior chemotherapy or radiotherapy for any brain tumor
• Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
• Definitive evidence of multifocal disease
• Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)
• Patients with infra-tentorial tumors are not eligible
• Prior history of neurologic or psychiatric disease believed to impact cognitive function
• The use of memantine during or following radiation is NOT allowed
• Severe, active co-morbidity defined as follows:
• Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment
• Transmural myocardial infarction within the last 6 months prior to registration; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)
• New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
• Serious and inadequately controlled arrhythmia at step 2 registration
• Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol
• Any other severe immunocompromised condition
• Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
• End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
• Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy
• Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction); note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Emory Proton Therapy Center — Atlanta, Georgia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
• MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
• Maryland Proton Treatment Center — Baltimore, Maryland, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• UM Upper Chesapeake Medical Center — Bel Air, Maryland, United States
• Central Maryland Radiation Oncology in Howard County — Columbia, Maryland, United States
• UM Baltimore Washington Medical Center/Tate Cancer Center — Glen Burnie, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• University of Kansas Cancer Center - North — Kansas City, Missouri, United States
• University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
• University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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