A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.
• Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis
• Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification
• Age ≥ 18 years
• Patients with one or several prior surgical procedure for a low-grade oligodendroglioma and who undergo a resurgery are eligible if they have not received prior radiotheray or chemotherapy and if the last histological diagnosis is a low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted
• Patients who undergo an initial follow-up after surgery or re-surgery are eligible if there is no evidence of anaplastic transformation on MRI (no new contrast enhancement, no obvious modification of the growth rate)
• Patients requiring an oncological treatment other than surgery because of one or more of the following characteristics:
‣ Progressive disease defined as documented growth prior to inclusion
⁃ Symptomatic disease defined as the presence of neurological or cognitive symptoms or refractory seizures defined as having both persistent seizures interfering with everyday life activities other than driving a car and three lines of anti-epileptic drug regimen had not worked, including at least one combination regimen.
⁃ Age ≥ 40 and any surgical therapy
⁃ Age \< 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)
• Willing and able to complete neurocognitive examination and the QOL
• Karnofsky performance status ≥ 60
• Laboratory values obtained between 21 days before inclusion andrandomization, respecting the following criteria:
• Absolute neutrophil count (ANC) ≥1500 /mm3
• Platelet count ≥100,000 / mm3
• Hemoglobin \> 9.0 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• SGOT (AST) ≤ 3 x ULN
• Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
• Provide informed written consent