A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a T… (NCT04702581) | Clinical Trial Compass
RecruitingPhase 3
A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
France280 participantsStarted 2021-12-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 ne…