Re-Irradiation of Progressive or Recurrent DIPG

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)

Study Overview

• Status: Recruiting
• Conditions: Recurrent or Progressive Diffuse Intrinsic Pontine Glioma
• Intervention / Treatment: Radiation: re-irradiation

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: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie Lafay-Cousin, MD; Phone Number: 1 403 955 2554; Email: lucie.lafay-cousin@ahs.ca
• Study Contact Backup: Name: Eric Bouffet, MD; Phone Number: 1 416 813 7457; Email: eric.bouffet@sickkids.ca

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia
      • Recruiting
      • The Children's Hospital at Westmead
      • Contact: Dinisha Govender, MD
  • Queensland
    • Brisbane, Queensland, Australia
      • Recruiting
      • Queensland Children's Hospital
      • Contact: Timothy Hassall, MD
  • Victoria
    • Clayton, Victoria, Australia
      • Recruiting
      • Monash Children's Hospital
      • Contact: Paul Wood, MD
    • Parkville, Victoria, Australia
      • Recruiting
      • Royal Children's Hospital
      • Contact: Jordan Hansford, MD
  • Western Australia
    • Perth, Western Australia, Australia
      • Recruiting
      • Perth Children's Hospital
      • Contact: Nick Gottardo, MD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Lucie Lafay-Cousin, MD; Phone Number: 403 955 2554; Email: lucie.lafay-cousin@ahs.ca
      • Contact: Tao Wang, MSc; Email: Tao.Wang@ahs.ca
    • Edmonton, Alberta, Canada
      • Recruiting
      • Stollery Children's Hospital
      • Contact: Susan Chafe, MD
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • BC Children's Hospital
      • Contact: Juliette Hukin, MD
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada
      • Recruiting
      • Janeway Child Health Centre
      • Contact: Lynette Bowes, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Recruiting
      • IWK Health Centre
      • Contact: Craig Erker, MD
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • McMaster Children's Hospital
      • Contact: Adam Fleming, MD
    • London, Ontario, Canada
      • Recruiting
      • Children's Hospital at London Health Sciences Centre
      • Contact: Shayna Zelcer, MD
    • Ottawa, Ontario, Canada
      • Recruiting
      • Children's Hospital of Eastern Ontario
      • Contact: Donna Johnston, MD
    • Toronto, Ontario, Canada
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Ute Bartels, MD
  • Quebec
    • Laval, Quebec, Canada
      • Recruiting
      • CHU de Quebec-Universite Laval
      • Contact: Samuele Renzi, MD
    • Montreal, Quebec, Canada
      • Recruiting
      • Montreal Children's Hospital
      • Contact: Sonia Skamene, MD
    • Montréal, Quebec, Canada
      • Recruiting
      • Centre Hospitalier Universitaire Sainte-Justine
      • Contact: Sebastian Perreault, MD
• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Starship Hospital
    • Contact: Karen Tsui, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
second progression-free survival	length of time from start of re-irradiation to subsequent progression of disease	up to 18 months from the start of re-irradiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	time from initial diagnosis of DIPG to death following re-irradiation	up to three years from initial diagnosis of DIPG

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Lucie Lafay-Cousin, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Stem Neoplasms; Infratentorial Neoplasms; Recurrence; Glioma; Diffuse Intrinsic Pontine Glioma
• Other Study ID Numbers: HREBA.CC16-0143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No