NCT05190172

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
240mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2022Dec 2045

First Submitted

Initial submission to the registry

July 15, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2045

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

July 15, 2021

Last Update Submit

April 27, 2026

Conditions

OligodendrogliomaOligodendroglioma, AnaplasticDiffuse Astrocytoma, IDH-Mutant

Keywords

proton therapyradiotherapyIDH-mutated diffuse grade II astrocytomaIDH-mutated diffuse grade III astrocytomaoligodendroglioma

Outcome Measures

Primary Outcomes (1)

  • First intervention free survival (FIFS) at 2 years

    Survival

    2 years

Secondary Outcomes (13)

  • Total fatigue score assessed by the fatigue questionnaire developed by T. Chalder et al.

    2, 5, 10 and 15 years

  • Change in cognitive functioning (composite score from CANTAB-tests) at 2 years

    5 months and 2, 5, 10 and 15 years

  • Overall survival

    Median and at 2, 5, 10 and 15 years

  • FIFS

    Median, 5, 10 and 15 years

  • Progression-free survival

    Median and at 2, 5, 10 and 15 years

  • +8 more secondary outcomes

Study Arms (2)

Radiation therapy with protons

EXPERIMENTAL

Radiation therapy with protons

Radiation: Radiation therapy

Radiation therapy with photons

ACTIVE COMPARATOR

Radiation therapy with photons at an University Hospital nearby subject's home address

Radiation: Radiation therapy

Interventions

Radiation therapyRADIATION

Radiation therapy either with protons or photons

Radiation therapy with photonsRadiation therapy with protons

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Prior treatment (except surgery) for diffuse glioma
  • Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years
  • Known CDKN2A/B homozygous deletion
  • Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up
  • Body weight \> 150 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (1)

  • Heggebo LC, Borgen IMH, Rylander H, Kiserud C, Nordenmark TH, Hellebust TP, Evensen ME, Gustavsson M, Ramberg C, Sprauten M, Magelssen H, Blakstad H, Moorthy J, Andersson K, Raunert I, Henry T, Moe C, Granlund C, Goplen D, Brekke J, Johannessen TA, Solheim TS, Marienhagen K, Humberset O, Bergstrom P, Agrup M, Dahl L, Gubanski M, Gojon H, Brahme CJ, Ryden I, Jakola AS, Vik-Mo EO, Lie HC, Asphaug L, Hervani M, Kristensen I, Rueegg CS, Olsen IC, Ledal RJ, Degsell E, Werlenius K, Blomstrand M, Brandal P. Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden. BMJ Open. 2023 Mar 20;13(3):e070071. doi: 10.1136/bmjopen-2022-070071.

    PMID: 36940951DERIVED

MeSH Terms

Conditions

OligodendrogliomaAstrocytoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Petter Brandal, MD PhD

    Head of Neurooncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petter Brandal, MD PhD

CONTACT

+47 22934000petter.brandal@ous-hf.no

Danielle Hagen

CONTACT

+4722934000carvan@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Experimental treatment arm with proton radiationtherapy * Standard treatment arm with photon radiationtherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurooncology

Study Record Dates

First Submitted

July 15, 2021

First Posted

January 13, 2022

Study Start

January 14, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2045

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

In accordance with Norwegian Data Protection Law, the dataset is only available by physical appearance at Oslo University Hospital, Norway upon request. To access data, please contact principal investigator Petter Brandal (petter.brandal@ous-hf.no). Data will not be shared before planned analyses are performed and published. The study protocol is also available upon request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available following publication of the primary and key secondary endpoints. The study protocol is available upon request from this date
Access Criteria
Physical appearance at Oslo University Hospital, Norway.

Locations

NO(1)