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

NCT04610229 | Completed DMC

• 1 other identifier: GLIORAD_15-18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme; Glioblastoma; Glioblastoma, Adult

Keywords

dose painting; hypofractionation; recurrent glioblastoma; tumour; radiotherapy; retreatment; brain

Outcome Measures

Primary Outcomes (1)

• Number of adverse events occuring after treatment

  Evaluation of side effects in order to assess the risk / benefit ratio. Values greater than G3 according to the CTCAE v.4.0 scale will be considered adverse events.

  3 months

Secondary Outcomes (6)

• Local control according to the RANO criteria

  3 months

• Incidence of radionecrosis

  3 months

• Proportion of patients alive 3 months after treatment

  3 months

• Change in health related global quality of life (QOL)

  3 months

• Change in health related quality of life (QOL) for brain cancer disease

  3 months

Study Arms (1)

Treated with hypofractionation

EXPERIMENTAL

1

Radiation: Hypofractionation guioded by dose painting

Interventions

Hypofractionation guioded by dose painting RADIATION

1

Treated with hypofractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• relapsed GBM after standard surgery-radio-chemotherapy treatment or other therapeutic lines or GBM secondary to anaplastic astrocytomas previously treated with RT and chemotherapy or recurrent anaplastic astrocytomas
• ECOG Performance Status 0-2, Performance Karnofsky Score\> 60.
• Written informed consent.
• Life expectancy\> 3 months.
• Availability of the patient to be followed for all the phases of the chemotherapy treatment and for the subsequent follow-up.-

You may not qualify if:

• Patients with KPS \<70%.
• Participation in other studies that involve the administration of experimental drugs or explicitly exclude the possibility of participating in other studies in general or in studies whose features include aspects of this study.
• Any concurrent medical or psychological condition that may prevent participation in the study or compromise the ability to provide informed consent.
• Pregnant and lactating patients

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Radiotherapy Unit Ausl Irccs Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Related Publications (6)

• Ciammella P, Podgornii A, Galeandro M, D'Abbiero N, Pisanello A, Botti A, Cagni E, Iori M, Iotti C. Hypofractionated stereotactic radiation therapy for recurrent glioblastoma: single institutional experience. Radiat Oncol. 2013 Sep 25;8:222. doi: 10.1186/1748-717X-8-222.

  PMID: 24066926 BACKGROUND

• Franco P, De Bari B, Ciammella P, Fiorentino A, Chiesa S, Amelio D, Pinzi V, Bonomo P, Vagge S, Fiore M, Comito T, Cecconi A, Mortellaro G, Bruni A, Trovo M, Filippi AR, Greto D, Alongi F; AIRO Giovani Italian Association of Radiation Oncology, Young Members Working Group. The role of stereotactic ablative radiotherapy in oncological and non-oncological clinical settings: highlights from the 7th Meeting of AIRO--Young Members Working Group (AIRO Giovani). Tumori. 2014 Nov-Dec;100(6):e214-9. doi: 10.1700/1778.19280.

  PMID: 25688503 BACKGROUND

• Filippi AR, Ciammella P, Piva C, Ragona R, Botto B, Gavarotti P, Merli F, Vitolo U, Iotti C, Ricardi U. Involved-site image-guided intensity modulated versus 3D conformal radiation therapy in early stage supradiaphragmatic Hodgkin lymphoma. Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):370-5. doi: 10.1016/j.ijrobp.2014.01.041. Epub 2014 Mar 7.

  PMID: 24613810 BACKGROUND

• Navarria P, Minniti G, Clerici E, Tomatis S, Pinzi V, Ciammella P, Galaverni M, Amelio D, Scartoni D, Scoccianti S, Krengli M, Masini L, Draghini L, Maranzano E, Borzillo V, Muto P, Ferrarese F, Fariselli L, Livi L, Pasqualetti F, Fiorentino A, Alongi F, di Monale MB, Magrini S, Scorsetti M. Re-irradiation for recurrent glioma: outcome evaluation, toxicity and prognostic factors assessment. A multicenter study of the Radiation Oncology Italian Association (AIRO). J Neurooncol. 2019 Mar;142(1):59-67. doi: 10.1007/s11060-018-03059-x. Epub 2018 Dec 4.

  PMID: 30515706 BACKGROUND

• Ciammella P, Galeandro M, D'Abbiero N, Podgornii A, Pisanello A, Botti A, Cagni E, Iori M, Iotti C. Hypo-fractionated IMRT for patients with newly diagnosed glioblastoma multiforme: a 6 year single institutional experience. Clin Neurol Neurosurg. 2013 Sep;115(9):1609-14. doi: 10.1016/j.clineuro.2013.02.001. Epub 2013 Feb 26.

  PMID: 23453151 BACKGROUND

• Orlandi M, Botti A, Sghedoni R, Cagni E, Ciammella P, Iotti C, Iori M. Feasibility of voxel-based Dose Painting for recurrent Glioblastoma guided by ADC values of Diffusion-Weighted MR imaging. Phys Med. 2016 Dec;32(12):1651-1658. doi: 10.1016/j.ejmp.2016.11.106. Epub 2016 Dec 16.

  PMID: 27989415 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• MAURO MI IORI, PhD

  MEDICAL PHYSISCS UNIT AUSL IRCCS REGGIO EMILIA ITALY

  PRINCIPAL INVESTIGATOR

• PATRIZIA PC CIAMMELLA, MD

  RADIOTHERAPY UNIT AUSL IRCCS REGGIO EMILIA ITALY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: October 30, 2020
• Study Start: February 1, 2016
• Primary Completion: August 12, 2019
• Study Completion: August 26, 2019
• Last Updated: June 12, 2025

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)