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NCT Number: NCT06093165

RE-irradiation of Diffuse MIdline Glioma paTients

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.

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Key information

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant Brain Diseases Brain Neoplasms Brain Stem Neoplasms Brain Tumor, Pediatric Central Nervous System Diseases Central Nervous System Neoplasms Diffuse Glioma Diffuse Intrinsic Pontine Glioma Glioma Infratentorial Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pontine Tumors Thalamic Tumor

Age range

12 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

REMIT is a non-randomized, prospective, investigator-initiated, phase II, multi-centre observational study with two inclusion groups, arm A and B. Arm A and B will be offered the same treatment.

Patients treated with primary radiotherapy 54Gy/30 fractions, either enrolled in the BIOMEDE 2.0 protocol or not, will be included in Arm A. DMG patients treated with any other total dose and fractionation than 54Gy/30F will be included in Arm B. The re-RT and follow up will be the same in both arms.

As treatment 20Gy/10 fractions is given as first time re-irradiation with extended follow up on toxicity, performance status and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Full recovery from all acute and subacute toxicities of 1st RT course
  • Clinical progression of symptoms and/or radiographic progression
  • Karnofsky performance status scale or Lansky Play Scale > 50% The performance status should not take the neurological deficits per se into account.

NB: Children and adults with a worsening performance status due to glioma-related motor deficit can be included.

  • Life expectancy > 12 weeks after start of reRT
  • Signed informed consent by patient and/or parents or legal guardian

Exclusion criteria

  • 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
  • Inability to complete the medical follow-up (geographic, social, or mental reasons)

Treatment and study plan

re-irradiation

Radiation

20Gy on 10 fractions

Primary outcomes

  1. To evaluate the safety of re-irradiation (reRT)

    Time frame: 4 weeks after end of re-irradiation

    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.

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.

    Time frame: 4 weeks after end of re-irradiation

    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.

  2. Palliative efficacy measured as symptom relief

    Time frame: 4 weeks after end of re-irradiation

    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.

  3. Other secondary outcomes

    Time frame: through study completion

    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.

Other outcomes

  1. Exploratory analyses

    Time frame: through study completion

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniella Østergaard

CONTACT

[email protected]

+4520822297

Maja V. Maraldo

CONTACT

[email protected]

+4535451117

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Karolinska University Hospital
  • Radiumhospitalet, Oslo University Hospital
  • Sahlgrenska University Hospital

Registry information

Acronym: REMIT

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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