Study of Re-irradiation at Relapse Versus RT and Multiple Elective rt Courses

• Status: Recruiting
• Trial end date: 2024-11-02
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, non-blinded, randomised two cohorts study on the efficacy of two different radiotherapy schedule for DIPG by using the same concomitant and post-radiotherapy systemic treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Johannes Gutenberg University Mainz; University of Roma La Sapienza; Wuerzburg University Hospital
• Treatments: Antibodies, Monoclonal; Nimotuzumab; Vinorelbine

Criteria

Inclusion Criteria:

• Patients from 2 to 21 years old will be eligible

• No previous treatment consented apart from steroids

• Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons)

• symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %

• no organ dysfunction; no pregnancy or breast-feeding

• Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory

• Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment.

Exclusion Criteria:

• Patients below 2 years or over 21

• Pre-treatment with radio or chemotherapy

• Neurofibromatosis 1

• Non-typical imaging

• Symptoms duration over 6 months, Lansky/Karnowski scores below 40%

• Metastatic disease as shown by MRI

• Organ dysfunction, pregnancy or breast-feeding

• Absence of parents, patient or tutor consent