Re-Irradiation of Progressive or Recurrent DIPG

Last updated: December 4, 2024
Sponsor: University of Calgary
Overall Status: Completed

Phase

N/A

Condition

Brain Cancer

Brain Tumor

Neurofibromatosis

Treatment

re-irradiation

Clinical Study ID

NCT03126266
HREBA.CC16-0143
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  1. Each site may accept a patient on study of any age that they have permission totreat 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 usingprotons 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 ofchemotherapy, 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 treatmentusing 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-tumourintervention

  11. The patient agrees to report and have recorded the use of all medications takenduring ReRAD therapy, from the time of diagnosis of progression or recurrence, thenthrough and after completion of, ReRAD therapy; this includes the use ofcomplementary, alternative and dietary therapies

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

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

  14. Consent, and, if applicable, assent, has been obtained according to institutionalstandards

Exclusion

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 asprescribed in this study.

  3. Patients who are receiving any other clinical trial of an anti-tumour intervention

Study Design

Total Participants: 27
Treatment Group(s): 1
Primary Treatment: re-irradiation
Phase:
Study Start date:
April 15, 2017
Estimated Completion Date:
November 25, 2024

Study 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.

Connect with a study center

  • The Children's Hospital at Westmead

    Westmead, New South Wales
    Australia

    Site Not Available

  • Queensland Children's Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • Monash Children's Hospital

    Clayton, Victoria
    Australia

    Site Not Available

  • Royal Children's Hospital

    Parkville, Victoria
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth, Western Australia
    Australia

    Site Not Available

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • BC Children's Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Janeway Child Health Centre

    Saint John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • McMaster Children's Hospital

    Hamilton, Ontario
    Canada

    Site Not Available

  • Children's Hospital at London Health Sciences Centre

    London, Ontario
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario
    Canada

    Site Not Available

  • CHU de Québec-Université Laval

    Laval, Quebec
    Canada

    Site Not Available

  • Montreal Children's Hospital

    Montreal, Quebec
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Sainte-Justine

    Montréal, Quebec
    Canada

    Site Not Available

  • Starship Hospital

    Auckland,
    New Zealand

    Site Not Available

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