Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
1p/19q Co-deletion, Anaplastic Astrocytoma, Diffuse Astrocytoma
About this trial
This is an interventional supportive care trial for 1p/19q Co-deletion
Eligibility Criteria
Inclusion Criteria:
- Prior to STEP 1 REGISTRATION
- Tumor tissue must be available for submission for central pathology review
- 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
- Only English speaking patients are eligible to participate as the cognitive and quality of life assessments are available only in English
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- Karnofsky performance status of >= 70 within 30 days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
- Bilirubin =< 1.5 upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
- BUN < 30 mg/dl
- Serum creatinine < 1.5 mg/dl
- Post-operative magnetic resonance (MR) imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are highly encouraged to obtain thin-slice (<1.5 mm) 3D T1 pre and post contrast and Axial T2/FLAIR sequences for planning purposes
- Prior to STEP 2 REGISTRATION
- The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R, TMT Parts A and B, and COWA
- 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 to step 2 registration
- Centrally reviewed histologically proven diagnosis of supratentorial, Word Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation
Exclusion Criteria:
- 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 step 2 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 step 2 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 step 2 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 step 2 registration, with the exception of the craniotomy for surgical resection
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 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 step 2 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
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Boca Raton Regional Hospital
- Miami Cancer InstituteRecruiting
- Emory Proton Therapy Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Northwestern UniversityRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maryland Proton Treatment CenterRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Central Maryland Radiation Oncology in Howard CountyRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Washington University School of MedicineRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Case Western Reserve UniversityRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- FHCC at Northwest Hospital
- University of Washington Medical Center - MontlakeRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (photon-based IMRT, temozolomide)
Arm II (proton beam radiation therapy, temozolomide)
Patients undergo photon-based IMRT QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity.
Patients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity.