Re-Irradiation of Progressive or Recurrent DIPG

Not Applicable

Completed

• Conditions: Recurrent or Progressive Diffuse Intrinsic Pontine Glioma
• Interventions: Radiation: re-irradiation

• Registration Number: NCT03126266
• Lead Sponsor: University of Calgary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2017-04-15
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving re-irradiation	re-irradiation	Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG

Primary Outcome Measures

Name	Time	Method
second progression-free survival	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

Name	Time	Method
overall survival	up to three years from initial diagnosis of DIPG	time from initial diagnosis of DIPG to death following re-irradiation

Trial Locations

Locations (18)

Perth Children's Hospital; 🇦🇺 Perth, Western Australia, Australia

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Janeway Child Health Centre; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada

The Children's Hospital at Westmead; 🇦🇺 Westmead, New South Wales, Australia

Monash Children's Hospital; 🇦🇺 Clayton, Victoria, Australia

Queensland Children's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada

CHU de Québec-Université Laval; 🇨🇦 Laval, Quebec, Canada

Starship Hospital; 🇳🇿 Auckland, New Zealand

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Centre Hospitalier Universitaire Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada