Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2017-04-15
2024-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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 Criteria
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
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Lucie Lafay-Cousin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU de Québec-Université Laval
Laval, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Starship Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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HREBA.CC16-0143
Identifier Type: -
Identifier Source: org_study_id