RE-irradiation of Diffuse MIdline Glioma paTients

Diffuse Intrinsic Pontine Glioma Clinical Trial

— REMIT  

Official title:

RE-irradiation of Diffuse MIdline Glioma paTients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093165
• Other study ID #: REMIT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: November 2029

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Daniella Østergaard
• Phone: +4520822297
• Email: daniella.elisabet.oestergaard.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Stem Neoplasms
• Brain Tumor, Pediatric
• Diffuse Glioma
• Diffuse Intrinsic Pontine Glioma
• Diffuse Midline Glioma, H3 K27M-Mutant
• Glioma
• Pontine Tumors

Intervention

Radiation:
• Re-irradiation
20Gy on 10 fractions

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital, Karolinska University Hospital, Radiumhospitalet, Oslo University Hospital, Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	through study completion
Primary	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.	4 weeks after end of re-irradiation
Secondary	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.	4 weeks after end of re-irradiation
Secondary	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.	4 weeks after end of re-irradiation
Secondary	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.	through study completion