Recurrent or Progressive Diffuse Intrinsic Pontine GliomaNCT03126266
Re-Irradiation of Progressive or Recurrent DIPG
A study testing re-irradiation in people with Recurrent or Progressive Diffuse Intrinsic Pontine Glioma, run by University of Calgary at 18 sites in 3 countries.
Trial summary
This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent or Progressive Diffuse Intrinsic Pontine Glioma
- What is being tested?
- re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 15 Apr 2017to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Canada12 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta
IWK Health Centre
Halifax, Nova Scotia
McMaster Children's Hospital
Hamilton, Ontario
CHU de Québec-Université Laval
Laval, Quebec
Children's Hospital at London Health Sciences Centre
London, Ontario
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
Montreal Children's Hospital
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Janeway Child Health Centre
St. John's, Newfoundland and Labrador
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
Australia5 sites
Queensland Children's Hospital
Brisbane, Queensland
Monash Children's Hospital
Clayton, Victoria
Royal Children's Hospital
Parkville, Victoria
Perth Children's Hospital
Perth, Western Australia
The Children's Hospital at Westmead
Westmead, New South Wales
About this study
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
This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)
Read the detailed 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.
- Being tested
- re-irradiation
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-irradiationRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving re-irradiation | Experimental | Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG Receives: Radiation: re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
second progression-free survival
length of time from start of re-irradiation to subsequent progression of disease
Measured: up to 18 months from the start of re-irradiation
Secondary outcomes (1)
overall survival
time from initial diagnosis of DIPG to death following re-irradiation
Measured: up to three years from initial diagnosis of DIPG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start15 Apr 2017
- Primary completion20 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Progressive Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie Lafay-Cousin, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126266
- Sponsor's protocol ID
- HREBA.CC16-0143
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2017
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03126266
- Acronym / sponsor ID
- HREBA.CC16-0143
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving re-irradiation | Experimental | Radiation: re-irradiationPatients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| re-irradiationif 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 | Radiation | Patients receiving re-irradiation |
Primary outcome
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
1 secondary outcome
overall survival
Time frame: up to three years from initial diagnosis of DIPG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Lafay-Cousin, MD principal investigator
University of Calgary
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing re-irradiation in people with Recurrent or Progressive Diffuse Intrinsic Pontine Glioma, run by University of Calgary at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
second progression-free survival (time frame: up to 18 months from the start of re-irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.