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NCT05190172: PRO-GLIO

PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas

Recruiting now NA Last updated 12 February 2025
What this trial tests

NA trial testing Radiation therapy in Oligodendroglioma in 225 participants. Currently enrolling.

Timeline
14 January 2022
Primary endpoint
31 December 2027
31 December 2043

Quick facts

Lead sponsorOslo University Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment225
Start date14 January 2022
Primary completion31 December 2027
Estimated completion31 December 2043
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 65, any sex, with Oligodendroglioma or Oligodendroglioma, Anaplastic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation. The infiltrative nature of IDH-mutated grade II and III diffuse glioma, however, renders proton therapy a potential problem. A randomized controlled trial (RCT) is the only option when trying to ensure that chances of long-term survival are not impaired seeking to reduce unwanted late treatment effects. Non-inferiority of proton therapy compared to photon irradiation is the primary endpoint of the RCT. Hence, PRO-GLIO has two main objectives. First, PRO-GLIO will evaluate if proton therapy is safe in patients with IDH-mutated grade II and III diffuse glioma, showing that survival figures at 2 years from radiotherapy are not poorer in the proton arm than in the photon arm. Second, we want to find the true number of patients in need of rehabilitation in both arms, and evaluate if proton therapy conveys a higher QoL than photon irradiation at 2 years from radiotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. How proton therapy fits into the management of adult intracranial tumors.
    Kotecha R, La Rosa A, Mehta MP. · · 2024 · cited 9× · PMID 38437667 · DOI 10.1093/neuonc/noad183
  2. Investigating survival, quality of life and cognition in PROton versus photon therapy for <i>IDH-</i>mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden.
    Heggebø LC, Borgen IMH, Rylander H, Kiserud C, et al · · 2023 · cited 8× · PMID 36940951 · DOI 10.1136/bmjopen-2022-070071
  3. Controversies in neuro-oncology: Focal proton versus photon radiation therapy for adult brain tumors.
    Eekers DBP, Zegers CML, Ahmed KA, Amelio D, et al · · 2024 · cited 7× · PMID 39006517 · DOI 10.1093/nop/npae040
  4. Changes in clinical management of diffuse IDH-mutated lower-grade gliomas: patterns of care in a 15-year period.
    Svenjeby C, Carstam L, Werlenius K, Bontell TO, et al · · 2022 · cited 5× · PMID 36434487 · DOI 10.1007/s11060-022-04136-y
  5. Management of Adult Patients With Isocitrate Dehydrogenase-Mutant Gliomas in Australia: An Expert Position Statement From the Cooperative Trials Group for Neuro-Oncology.
    Pinkham MB, Sim HW, Jeffree RL, Lasocki A, et al · · 2026 · PMID 41881841 · DOI 10.1111/ajco.70070
  6. Proton versus photon radiotherapy in adults with primary brain tumors evaluating functional survival: a phase 3 randomized controlled trial study protocol (PRIDE).
    Dasgupta A, Ghosh S, Chatterjee A, Kannan S, et al · · 2026 · PMID 41689093 · DOI 10.1186/s13014-025-02785-7
  7. Proton therapy for adult type IDH-mutated glioma: Proglio-1, a multicenter retrospective study.
    Goliot N, Jouglar E, Jacob J, Christy F, et al · · 2025 · PMID 40764578 · DOI 10.1186/s13014-025-02702-y
  8. Protons or Photons in Pituitary Neuroendocrine Tumors-That Is Not the Question.
    Heggebø LC, Garrote FLB, Fjæra LF, Hervani M, et al · · 2025 · PMID 40678408 · DOI 10.1016/j.ijpt.2025.101194

Verify or expand the search:

Other trials of Radiation therapy

Trials testing the same drug.

Other recruiting trials for Oligodendroglioma

Currently open trials in the same condition.

Other Oslo University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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