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

Summary

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.

Conditions

• Oligodendroglioma
• Oligodendroglioma, Anaplastic
• Diffuse Astrocytoma, IDH-Mutant

Interventions

RADIATION

Radiation therapy

Radiation therapy either with protons or photons

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• The Skandion Clinic

  collaborator UNKNOWN

• University Hospital of North Norway

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• Ôrebro University Hospital

  collaborator UNKNOWN

• Uppsala University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Ryhov County Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Petter Brandal, MD PhD · Head of Neurooncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-14

Primary Completion

2030-12-31

Completion

2045-12-31

Countries

• Norway

Study Locations