Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT03180502
Eligibility Criteria:
Inclusion Criteria:
* 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
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 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
* Patients known to have hypersensitivity to dacarbazine (DTIC) are not eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03180502
Study Brief:
Protocol Section:
NCT03180502