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Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Primary Purpose

Pediatric Brain Stem Glioma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypofractionated Arm (1)
Hypofractionated Arm (2)
Conventional Arm (3)
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Brain Stem Glioma focused on measuring Diffuse Intrinsic Pontine Glioma (DIPG), Hypofractionated Radiotherapy, Radiotherapy, Median survival

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma
  2. Aged 2-18years,
  3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
  4. No performance criteria were required for entry onto the study.

Exclusion Criteria:

  • Children were not eligible if they had received any prior therapy other than steroids Treatment

Sites / Locations

  • Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Hypofractionated Arm (1)

Hypofractionated Arm (2)

Conventional Arm (3)

Arm Description

A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed

The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.

The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.

Outcomes

Primary Outcome Measures

Median overall-free survival

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
June 9, 2013
Last Updated
August 3, 2021
Sponsor
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT01878266
Brief Title
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Official Title
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.
Detailed Description
In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Brain Stem Glioma
Keywords
Diffuse Intrinsic Pontine Glioma (DIPG), Hypofractionated Radiotherapy, Radiotherapy, Median survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated Arm (1)
Arm Type
Experimental
Arm Description
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed
Arm Title
Hypofractionated Arm (2)
Arm Type
Experimental
Arm Description
The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.
Arm Title
Conventional Arm (3)
Arm Type
Other
Arm Description
The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Arm (1)
Intervention Description
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Arm (2)
Intervention Description
The total dose to 4500 cGy in 15 fractions in 3 weeks
Intervention Type
Radiation
Intervention Name(s)
Conventional Arm (3)
Intervention Description
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
Primary Outcome Measure Information:
Title
Median overall-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed patients with a diffuse intrinsic brainstem glioma Aged 2-18years, Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs. No performance criteria were required for entry onto the study. Exclusion Criteria: Children were not eligible if they had received any prior therapy other than steroids Treatment
Facility Information:
Facility Name
Children's Cancer Hospital Egypt 57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

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