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A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

ConditionsOligodendrogliomaLow-grade Oligodendroglioma1p19q Codeletion
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant and nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception for up to 6 months following the completion of PCV.

Received any prior radiation therapy or chemotherapy for any CNS neoplasm.

Co-morbid systemic illnesses or other severe concurrent disease which would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PCV chemotherapy

    Drug

    1. cycle of PCV chemotherapy is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally 6 cycles are given.

  • Radiotherapy and PCV chemotherapy

    Drug

    Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique. Followed by 6 cycles of PCV chemotherapy 1 cycle of PCV is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: PCV aloneExperimental treatment 1 intervention
Group B: RT + PCVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival without neurocognitive deterioration

Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study randomization to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.

Time frame
During 9 years

Secondary outcomes

1

Progression free survival

Time from study randomization to the time of progression of the tumor

Time frame
During 9 years
2

Overall survival

Time from study randomization to the time of death

Time frame
During 9 years

Other outcomes

Sponsors and contacts

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Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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