Re-Irradiation of Progressive or Recurrent DIPG

NCT03126266 | Completed DMC

• 1 other identifier: HREBA.CC16-0143
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 18

Brief Summary

This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)

Conditions

Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  up to three years from initial diagnosis of DIPG

Study Arms (1)

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

Radiation: re-irradiation

Interventions

re-irradiation RADIATION

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

Patients receiving re-irradiation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (18)

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Location

Queensland Children's Hospital

Brisbane, Queensland, Australia

Location

Monash Children's Hospital

Clayton, Victoria, Australia

Location

Royal Children's Hospital

Parkville, Victoria, Australia

Location

Perth Children's Hospital

Perth, Western Australia, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

Children's Hospital at London Health Sciences Centre

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

CHU de Québec-Université Laval

Laval, Quebec, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Starship Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Recurrence

Interventions

Re-Irradiation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment

Study Officials

• Lucie Lafay-Cousin, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: April 15, 2017
• Primary Completion: November 20, 2024
• Study Completion: November 25, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (1); CA (12)