RE-irradiation of Diffuse MIdline Glioma paTients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorRigshospitalet, Denmark

About this trial

The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG). The study will introduce a standard re-irradiation treatment schedule for DMG patients who have progressed following primary treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diffuse midline glioma diagnosis: verified radiologically or histologically Biopsy is not mandatory for REMIT

Age ≥ 12 months to ≤21 years.

Min. 180 days/6 months have elapsed from the first day of the 1st RT course

1st course of radiotherapy

Disqualifiers

Presence of leptomeningeal spread or multifocal disease on MRI at progression

Other co-morbidity that according to the treating physician would impair participation in the study

>1 course of radiotherapy

Neurofibromatosis type 1

Trial design

Design model

Parallel

Treatments tested in this trial

  • Re-irradiation

    Radiation

    20Gy on 10 fractions

Treatment groups

59 Participants
are divided into 2 treatment groups
Group A: AOther 1 intervention
Group B: BOther 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the safety of re-irradiation (reRT)

The primary endpoint will be the cumulative incidence of grade ≥4 CTCAE (The NCI Common Terminology Criteria for Adverse Events) events measured 4 weeks after the last day of reRT.

Time frame
4 weeks after end of re-irradiation

Secondary outcomes

1

The key secondary objective is to prospectively validate the palliative efficacy of reRT of DMG. Palliative efficacy is evaluated by two endpoints: overall survival and symptom relief.

Palliative efficacy measured as overall survival will be reported as 1) from date of diagnosis to date of death by any cause, and 2) from date of first radiological and/or clinical progression to date of death by any cause.

Time frame
4 weeks after end of re-irradiation
2

Palliative efficacy measured as symptom relief

Symptom relief measured by 1) clinical performance status (Karnofsky or Lansky) assessed every second week, 2) a modified PEDI score before, during and 4 weeks after reRT, 3) steroid dose levels measured every second week, and 4) quality of life monitored before, during and 4 weeks after re-irradiation with PedsQL Cancer module questionnaire.

Time frame
4 weeks after end of re-irradiation
3

Other secondary outcomes

Other secondary objectives are further defined as: * Image-guided characterization of the anatomical site of progression compared to the primary lesion. * Assessment of cumulated radiation dose to critical structures in the brain following the initial and reRT treatment.

Time frame
through study completion

Other outcomes

1

Exploratory analyses

* Delineation study A comparison of variations in delineation in tumour volume among the participating institutions. This will improve the delineation-related uncertainty and, consequently, the applied margins (and hence irradiated volume) can be diminished. This will ensure a more uniform treatment across countries. * The impact of reRT on the patients and their families An analysis of the value of reRT in terms of the practical, emotional, and existential impact on patients and their families. This will be done by using a qualitative method including interviewing the parents of a subgroup of the included patients. * Referral patterns A characterisation of referral patterns of DMG patients to reRT. This will be assessed through a screenings log of all DMG patients in the participating institutions. Date of diagnosis, date of death, reRT offered yes/no, and reason for not giving reRT will be registered prospectively.

Time frame
through study completion

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Aarhus University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska University Hospital

Collaborator

Radiumhospitalet, Oslo University Hospital

Collaborator

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