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Re-Irradiation of Progressive or Recurrent DIPG

Primary Purpose

Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
re-irradiation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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:

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 as prescribed in this study.
  3. Patients who are receiving any other clinical trial of an anti-tumour intervention

Sites / Locations

  • The Children's Hospital at WestmeadRecruiting
  • Queensland Children's HospitalRecruiting
  • Monash Children's HospitalRecruiting
  • Royal Children's HospitalRecruiting
  • Perth Children's HospitalRecruiting
  • Alberta Children's HospitalRecruiting
  • Stollery Children's HospitalRecruiting
  • BC Children's HospitalRecruiting
  • Janeway Child Health CentreRecruiting
  • IWK Health CentreRecruiting
  • McMaster Children's HospitalRecruiting
  • Children's Hospital at London Health Sciences CentreRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • CHU de Québec-Université LavalRecruiting
  • Montreal Children's HospitalRecruiting
  • Centre Hospitalier Universitaire Sainte-JustineRecruiting
  • Starship HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients receiving re-irradiation

Arm Description

Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG

Outcomes

Primary Outcome Measures

second progression-free survival
length of time from start of re-irradiation to subsequent progression of disease

Secondary Outcome Measures

overall survival
time from initial diagnosis of DIPG to death following re-irradiation

Full Information

First Posted
April 19, 2017
Last Updated
July 31, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT03126266
Brief Title
Re-Irradiation of Progressive or Recurrent DIPG
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients receiving re-irradiation
Arm Type
Experimental
Arm Description
Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG
Intervention Type
Radiation
Intervention Name(s)
re-irradiation
Intervention Description
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
Primary Outcome Measure Information:
Title
second progression-free survival
Description
length of time from start of re-irradiation to subsequent progression of disease
Time Frame
up to 18 months from the start of re-irradiation
Secondary Outcome Measure Information:
Title
overall survival
Description
time from initial diagnosis of DIPG to death following re-irradiation
Time Frame
up to three years from initial diagnosis of DIPG

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Lafay-Cousin, MD
Phone
1 403 955 2554
Email
lucie.lafay-cousin@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Bouffet, MD
Phone
1 416 813 7457
Email
eric.bouffet@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucie Lafay-Cousin, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinisha Govender, MD
Facility Name
Queensland Children's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Hassall, MD
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Wood, MD
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Hansford, MD
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Gottardo, MD
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Lafay-Cousin, MD
Phone
403 955 2554
Email
lucie.lafay-cousin@ahs.ca
First Name & Middle Initial & Last Name & Degree
Tao Wang, MSc
Email
Tao.Wang@ahs.ca
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Chafe, MD
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette Hukin, MD
Facility Name
Janeway Child Health Centre
City
Saint John's
State/Province
Newfoundland and Labrador
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynette Bowes, MD
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Erker, MD
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Fleming, MD
Facility Name
Children's Hospital at London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shayna Zelcer, MD
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Johnston, MD
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ute Bartels, MD
Facility Name
CHU de Québec-Université Laval
City
Laval
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuele Renzi, MD
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Skamene, MD
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Perreault, MD
Facility Name
Starship Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Tsui, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Re-Irradiation of Progressive or Recurrent DIPG

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