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RecruitingLast updated: 9 October 2023

ReRAD: This phase II trial is evaluating the repeat administration of radiotherapy to a previously exposed region of the body, with the aim of treating people with Diffuse Intrinsic Pontine Glioma that is getting worse or has recently come backReRAD: A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

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 patients with Diffuse Intrinsic Pontine Glioma.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People0 - 17

Phase

II

Trial Acronym

ReRAD

More information

Trial Identifiers

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Trial sponsor

University of Calgary

Scientific Title

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

Eligibility

Inclusion

  1. 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.
  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

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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