Re-Irradiation of Progressive or Recurrent DIPG

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    27
  • sponsor
    University of Calgary
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Updated on 24 March 2022
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Summary

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

Description

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.

Details
Condition Recurrent or Progressive Diffuse Intrinsic Pontine Glioma
Treatment re-irradiation
Clinical Study IdentifierNCT03126266
SponsorUniversity of Calgary
Last Modified on24 March 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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