Re-Irradiation of Progressive or Recurrent DIPG

Study Overview
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Brief Summary
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This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)

Detailed Description
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Study therapy will consist of radiation therapy (RT) given over 17 treatment days (for 30.6 Gy in fractions of 1.8 Gy) or 20 treatment days (for 36 Gy in 1.8 Gy fractions), depending on the time from completion of the first course of RT. Treatment days will generally be weekdays, not including statutory holidays.

Official Title
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ReRAD: A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

Conditions
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Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Intervention / Treatment
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* Radiation: re-irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of these criteria must be met for a patient to be eligible for this study: Each site may accept a patient on study of any age that they have permission to treat and follow on study per their institutional policy. The patient has no evidence of metastases on cranial or spinal MR imaging The patient has received RT in the past, given to a total cumulative dose of <60 Gy; prior radiation using opposed lateral fields, conformal 3-D fields, IMRT or using protons is acceptable At least 180 days have elapsed from the last day of primary RT for DIPG The patient has recovered from all acute and subacute toxicities of prior RT and of chemotherapy, if chemotherapy was utilized in the past The patient has been off all anti-tumour therapy for at least 14 days The patient has a Lansky score of 40% or higher The patient has a life expectancy anticipated to be at least 8 weeks with treatment using re-irradiation, with or without dexamethasone The patient has no uncontrolled medical condition (e.g., seizures, diabetes, infection) that would interfere with the delivery of rRT The patient agrees to not enroll on any other clinical trial of an anti-tumour intervention The patient agrees to report and have recorded the use of all medications taken during ReRAD therapy, from the time of diagnosis of progression or recurrence, then through and after completion of, ReRAD therapy; this includes the use of complementary, alternative and dietary therapies The patient is treated at a site where the study is approved by the local ethics board Males and females of child-bearing potential must agree to use effective birth control measures during rRT Consent, and, if applicable, assent, has been obtained according to institutional standards Exclusion Criteria: If the patient fulfills any of these criteria, then he or she will not be eligible for the study: Females who are pregnant, due to risks from rRT on the developing fetus. Any patient with a condition that prohibits the planned delivery of rRT as prescribed in this study. Patients who are receiving any other clinical trial of an anti-tumour intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving re-irradiation<br>Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG | Radiation: re-irradiation<br>* if DIPG has progressed or recurred at 180 days or later from completion of primary radiation therapy, a second course of radiation therapy will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| second progression-free survival | length of time from start of re-irradiation to subsequent progression of disease | up to 18 months from the start of re-irradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time from initial diagnosis of DIPG to death following re-irradiation | up to three years from initial diagnosis of DIPG |