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Completed

NCT Number: NCT03126266

Re-Irradiation of Progressive or Recurrent DIPG

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

re-irradiation

Radiation

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

Primary outcomes

  1. second progression-free survival

    Time frame: up to 18 months from the start of re-irradiation

    length of time from start of re-irradiation to subsequent progression of disease

Secondary outcomes

  1. overall survival

    Time frame: up to three years from initial diagnosis of DIPG

    time from initial diagnosis of DIPG to death following re-irradiation

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2017
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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