E3F05 Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Patients will be randomized to treatment Arm A or treatment Arm B. Patients in treatment Arm A will receive radiotherapy alone as defined in section 5.2. Patients in treatment Arm B will receive radiotherapy as defined in section 5.2 in addition to concomitant and subsequent chemotherapy as defined in section 5.3.
Age > 18 years.
Tumors must be supratentorially located.
Pathological diagnosis of astrocytoma grade 2, oligodendroglioma grade 2, or oligoastrocytoma grade 2 (mixed glioma containing astrocytoma and oligodendroglioma). Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthastrocytoma, or dysembryoplastic neuroepithelial tumors are not eligible.
NOTE: If the pathology from multiple procedures supports the diagnosis of a brain tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma must be the most recent pathological diagnosis, and a pathological diagnosis of a grade 3 or grade 4 glioma must not have been made at any time.
Patients must have paraffin-embedded tumor specimen available for submission for confirmation of pathological diagnosis and determination of 1p/19q deletion status.
NOTE: It is recommended that patients not be Pre-registered until the required tumor specimens are on hand and ready for submission as outlined in Section 10. If submission of tissue will be submitted more than 5 working days after pre-registration, immediately notify the Mayo Clinic Cytogenetics Laboratory via email: ecog.E3F05_TISSUE@jimmy.harvard.edu
The patient must currently have at least one of the following:
Uncontrolled symptoms, defined as any of the below:
Headaches associated with mass effect
Uncontrolled seizures despite 2 different antiepileptic drug regimens (i.e., 2 antiepileptic drugs tested either sequentially or in combination)
Focal neurological symptoms
Cognitive symptoms or deficits
Tumor progression by serial MRIs, defined as any of the below:
New or progressive enhancement
New or progressive T2 or FLAIR signal abnormality
Age ≥ 40 years.
NOTE: Patients aged less than 40 whose only symptom of low-grade glioma is
seizures that are well-controlled on antiepileptic drugs, and who have no evidence of radiographic progression, are ineligible. The rationale is that such patients have a relatively good prognosis and are often managed expectantly with observation. Excluding such patients will maintain similar eligibility requirements with the ongoing EORTC trial comparing radiation to temozolomide for patients with low-grade gliomas.
Patient must be able to undergo MRI with and without contrast. Patients who are unable to undergo MRI are ineligible.
MRI and chest x-ray within 6 weeks prior to pre-registration. A postoperative MRI is required for all patients who underwent open biopsy, or resection, but is not mandatory following stereotactic biopsy.
Karnofsky performance status > 60%.
Patients who have undergone gross total resection and have no detectable residual disease are eligible.