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

Study acronym: POLO
StatusRecruiting
PhasePhase 3
Started2021-12-07
View on ClinicalTrials.gov ↗

Amendment history

2026-01-28
Study Status, Contacts/Locations v9
Study sites26 entries, revised
InstitutCentre de CancérologieLutte StrasbourgContre Europele Cancer PAUL STRAUSS
2026-01-23
Study Status v8
Re-verified, no change to tracked fields
2025-03-12
Study Status, Contacts/Locations v7
Study sitesdetails revised at 12 of 26 sites
2024-03-15
Study Status v6
Re-verified, no change to tracked fields
2023-06-01
Study Status, Eligibility v5
Eligibility criteria+126 characters
[...] 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 [...] e examination and the QOL Karnofsky performance status ≥ 60 The following laboratoryLaboratory values obtained ≤between 21 days priorbefore toinclusion registrationandrandomization, respecting the following criteria: Absolute neutrophil count (ANC) ≥1500 /mm3 Platelet count [...] would be considered as a treatment for the primary neoplasm. (except specific inhibitors of IDH) Other active malignancy within 5 years of registration. [...]
Show 4 earlier versions
2023-02-14
Study Status v4
Re-verified, no change to tracked fields
2022-06-14
Study Status, Contacts/Locations v3
Study sitescontacts updated at 2 of 26 sites
2021-12-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2030-06→2030-12
Completion date2030-06→2030-12
Start dateestimated 2021-06→confirmed 2021-12-07
Study sites25→26
2021-04-13
Study Identification, Study Status v1
Primary completion date2030-02→2030-06
Completion date2030-02→2030-06
Start date2021-02→2021-06
2021-01-07
Original filing
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.
Trial Details
NCT Number NCT04702581
Lead Sponsor Hospices Civils de Lyon
Conditions Oligodendroglioma, Low-grade Oligodendroglioma, 1p19q Codeletion
Enrollment 280 participants
Start Date 2021-12-07
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-29