Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03126266 : Re-Irradiation of Progressive or Recurrent DIPG
PhaseN/A
AgesMin: N/A Max: 17 Years
Eligibility
Inclusion Criteria:

All of these criteria must be met for a patient to be eligible for this study:

1. The patient is 17 years of age of younger at the time of first or second relapse or
progression of DIPG

2. The patient has no evidence of metastases on cranial or spinal MR imaging

3. 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

4. At least 180 days have elapsed from the last day of primary RT for DIPG

5. The patient has recovered from all acute and subacute toxicities of prior RT and of
chemotherapy, if chemotherapy was utilized in the past

6. The patient has been off all anti-tumour therapy for at least 14 days

7. The patient has a Lansky score of 40% or higher

8. The patient has a life expectancy anticipated to be at least 8 weeks with treatment
using re-irradiation, with or without dexamethasone

9. The patient has no uncontrolled medical condition (e.g., seizures, diabetes,
infection) that would interfere with the delivery of rRT

10. The patient agrees to not enroll on any other clinical trial of an anti-tumour
intervention

11. 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

12. The patient is treated at a site where the study is approved by the local ethics board

13. Males and females of child-bearing potential must agree to use effective birth control
measures during rRT

14. 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:

1. Females who are pregnant, due to risks from rRT on the developing fetus.

2. Any patient with a condition that prohibits the planned delivery of rRT as prescribed
in this study.

3. Patients who are receiving any other clinical trial of an anti-tumour intervention
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03126266      |      Link to official Clinicaltrials.gov listing
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