Re-Irradiation of Progressive or Recurrent DIPG
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03126266 |
Recruitment Status :
Recruiting
First Posted : April 24, 2017
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent or Progressive Diffuse Intrinsic Pontine Glioma | Radiation: re-irradiation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ReRAD: A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma |
Actual Study Start Date : | April 15, 2017 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients receiving re-irradiation
Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG
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Radiation: re-irradiation
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 |
- 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
- overall survival [ Time Frame: up to three years from initial diagnosis of DIPG ]time from initial diagnosis of DIPG to death following re-irradiation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126266
Contact: Lucie Lafay-Cousin, MD | 1 403 955 2554 | lucie.lafay-cousin@ahs.ca | |
Contact: Eric Bouffet, MD | 1 416 813 7457 | eric.bouffet@sickkids.ca |

Principal Investigator: | Lucie Lafay-Cousin, MD | University of Calgary |
Responsible Party: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT03126266 |
Other Study ID Numbers: |
HREBA.CC16-0143 |
First Posted: | April 24, 2017 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glioma Diffuse Intrinsic Pontine Glioma Recurrence Disease Attributes Pathologic Processes Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Brain Stem Neoplasms Infratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |