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Re-Irradiation of Progressive or Recurrent DIPG

This study is not yet open for participant recruitment.
Verified March 2017 by University of Calgary
Sponsor:
ClinicalTrials.gov Identifier:
NCT03126266
First Posted: April 24, 2017
Last Update Posted: April 24, 2017
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.
Collaborators:
Meagan's Walk
Janeway Child Health Centre
IWK Health Centre
St. Justine's Hospital
Montreal Children's Hospital of the MUHC
CHU de Quebec-Universite Laval
Children's Hospital or Eastern Ontario
The Hospital for Sick Children
McMaster Children's Hospital
Children's Hospital Medical Center, Cincinnati
CancerCare Manitoba
Stollery Children's Hospital
Alberta Children's Hospital
British Columbia Children's Hospital
Information provided by (Responsible Party):
University of Calgary
  Purpose
This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)

Condition Intervention
Recurrent or Progressive Diffuse Intrinsic Pontine Glioma Radiation: re-irradiation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • overall survival [ Time Frame: up to three years from initial diagnosis of DIPG ]
    time from initial diagnosis of DIPG to death following re-irradiation


Estimated Enrollment: 25
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.
  Eligibility

Information from the National Library of Medicine

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:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 of 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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Douglas Strother, MD 1 403 955 7203 doug.strother@ahs.ca
Contact: Eric Bouffet, MD 1 416 813 7457 eric.bouffet@sickkids.ca

Sponsors and Collaborators
University of Calgary
Meagan's Walk
Janeway Child Health Centre
IWK Health Centre
St. Justine's Hospital
Montreal Children's Hospital of the MUHC
CHU de Quebec-Universite Laval
Children's Hospital or Eastern Ontario
The Hospital for Sick Children
McMaster Children's Hospital
Children's Hospital Medical Center, Cincinnati
CancerCare Manitoba
Stollery Children's Hospital
Alberta Children's Hospital
British Columbia Children's Hospital
Investigators
Principal Investigator: Douglas Strother, MD University of Calgary
  More Information

Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03126266     History of Changes
Other Study ID Numbers: HREBA.CC16-0143
First Submitted: April 19, 2017
First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: March 2017
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

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue


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