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Re-Irradiation of Progressive or Recurrent DIPG

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ClinicalTrials.gov Identifier: NCT03126266
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Janeway Children's Health and Rehabilitation Centre
IWK Health Centre
St. Justine's Hospital
Montreal Children's Hospital of the MUHC
CHU de Quebec-Universite Laval
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
McMaster Children's Hospital
London Health Sciences Centre
CancerCare Manitoba
Stollery Children's Hospital
Alberta Children's Hospital
British Columbia Children's Hospital
Information provided by (Responsible Party):
University of Calgary

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE April 15, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03126266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
overall survival [ Time Frame: up to three years from initial diagnosis of DIPG ]
time from initial diagnosis of DIPG to death following re-irradiation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-Irradiation of Progressive or Recurrent DIPG
Official Title  ICMJE ReRAD: A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma
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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Progressive Diffuse Intrinsic Pontine Glioma
Intervention  ICMJE 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
Study Arms 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
Intervention: Radiation: re-irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  1. The patient is 17 years of age or younger at the time of first or second relapse or progression of DIPG
  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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Douglas Strother, MD 1 403 955 7203 doug.strother@ahs.ca
Contact: Eric Bouffet, MD 1 416 813 7457 eric.bouffet@sickkids.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126266
Other Study ID Numbers  ICMJE HREBA.CC16-0143
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • Janeway Children's Health and Rehabilitation Centre
  • IWK Health Centre
  • St. Justine's Hospital
  • Montreal Children's Hospital of the MUHC
  • CHU de Quebec-Universite Laval
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • McMaster Children's Hospital
  • London Health Sciences Centre
  • CancerCare Manitoba
  • Stollery Children's Hospital
  • Alberta Children's Hospital
  • British Columbia Children's Hospital
Investigators  ICMJE
Principal Investigator: Douglas Strother, MD University of Calgary
PRS Account University of Calgary
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP