Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
0 - 17
Clinical summary
Summary
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 on weekdays.
Conditions
This trial is treating people with Diffuse Intrinsic Pontine Glioma
Eligibility
Inclusion
- 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
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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You are currently being treated on a clinical trial.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
University of Calgary
Scientific Title
A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma
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