NCT04610229: GLIORAD

Safety of IMRT Treatment With Inhomogeneous Dose in Patients With Relapsed High-grade Gliomas.

Completed NA Last updated 12 June 2025

What this trial tests

NA trial testing Hypofractionation guioded by dose painting in Glioblastoma Multiforme in 12 participants. Completed in 26 August 2019.

Timeline

1 February 2016

Primary endpoint
12 August 2019

26 August 2019

Quick facts

Lead sponsor	Azienda USL Reggio Emilia - IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 February 2016
Primary completion	12 August 2019
Estimated completion	26 August 2019
Sites	1 location across Italy

Drugs / interventions tested

• Hypofractionation guioded by dose painting

Conditions studied

• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• Glioblastoma — all drugs for Glioblastoma →
• Glioblastoma, Adult — all drugs for Glioblastoma, Adult →

Sponsor

Azienda USL Reggio Emilia - IRCCS — full company profile →

Who can join

18 and older, any sex, with Glioblastoma Multiforme or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Relapsed GBMs have a life expectancy of a few months and re-radiation has proven to be safe in terms of toxicity and effective in increasing OS. One of our studies \[Ciammella P, 2013, 8:222\] reported a median survival of 9.5 months in patients with recurrent GBM and treated with stereotactic radiotherapy with a total dose of 25 Gy in 5 consecutive sessions, in which the dose was prescribed to 70% isodose with a homogeneous gradient towards the center of the target volume. The identification with functional imaging of specific areas with higher tumor cell density, and the possibility of delivering precisely, thanks to the most advanced therapy units, different doses to the different sub-volumes, can lead to an increase in the maximum dose that can be delivered at the expense of the most aggressive areas (with a greater effect on the tumor), compared to smaller doses in areas with lower signal alteration. This selectivity of the doses should allow an increase in the efficacy of the therapy and therefore a hypothetical increase in local control, compared to a radio-induced toxicity on the surrounding healthy tissues almost comparable to that achieved with the previous hypofractionated treatments \[Ciammella P, 2013\]. In fact, delivering many high doses to the entire volume would result in an excess of radio-induced necrosis within the irradiated regions with high dose, as well as the impossibility of minimizing the doses on healthy areas and / or on non-neoplastic critical areas keeping them at internal dose ranges related to minimal and acceptable toxicity levels. Since there are no studies providing clear indications on the acute and late toxicity of irradiated healthy tissues that have already been the subject of a first course of radiotherapy (STUPP), the choice of safety is the primary objective of the study.

Publications & conference data

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

1. Safety of Inhomogeneous Dose Distribution IMRT for High-Grade Glioma Reirradiation: A Prospective Phase I/II Trial (GLIORAD TRIAL).
   Ciammella P, Cozzi S, Botti A, Giaccherini L, et al · · 2022 · cited 6× · PMID 36230525 · DOI 10.3390/cancers14194604
2. A Pipeline for MRI-Guided dose painting by number radiation Therapy: GLIORAD - a phase I-II clinical trial in recurrent glioblastoma.
   Botti A, Sghedoni R, Orlandi M, Paolani G, et al · · 2026 · PMID 41903279 · DOI 10.1016/j.ejmp.2026.105773