Pulsed Low-Dose-Rate Radiotherapy for Diffuse Midline Glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I study evaluates the tolerability and safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) in patients with diffuse midline glioma, focusing on a predominantly pediatric population. The trial aims to determine if pLDRT reduces treatment-related toxicity while maintaining potential benefits for tumor control and subsequent chemotherapy delivery. Eligible participants include those with radiological or histological confirmation of DMG, who can stay in position for treatment or undergo sedation, and have consent from guardians or patients aged 18 or older. Exclusion criteria include refusal of radiotherapy, concurrent chemotherapy, leptomeningeal spread, pregnancy in post-pubertal females, or prior brainstem radiotherapy. The lead sponsor is Centro di Riferimento Oncologico - Aviano, with participation at IRCCS Aviano in Italy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
* Ability to maintain the treatment position or undergo sedation, if required.
* Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.

Exclusion Criteria:

* Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
* Concurrent chemotherapy.
* Leptomeningeal dissemination of disease.
* Ongoing pregnancy (for post-pubertal female patients).
* Previous radiotherapy to the brainstem.

Where it's running

• Centro di Riferimento Oncolgico -IRCCS
  Aviano, Pordenone, Italy Recruiting

Study contacts

• Study coordinator: Elisa Coassin, MD
• Email: ecoassin@cro.it
• Phone: +39 0434 659632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.