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Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Primary Purpose

Pediatric Brain Stem Glioma

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Hypofractionated radiotherapy

Conventional arm

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
Patients were required to 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.
The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast in three series, as well as diffusion imaging.
Symptoms & signs of less than 3 months duration

Exclusion Criteria:

Children were not eligible if they had received any prior therapy other than steroid
The diagnosis of exophytic brainstem glioma

Sites / Locations

Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypofractionated arm

Conventional arm

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 with the established conventional regimen: 54 Gy in 30 fractions giving 1.8 Gy per fraction.

Outcomes

Primary Outcome Measures

Median overall-free survival

Progression-free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT01635140

First Posted

June 28, 2012

Last Updated

July 6, 2012

Sponsor

Children's Cancer Hospital Egypt 57357

1. Study Identification

Unique Protocol Identification Number

NCT01635140

Brief Title

Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Official Title

Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (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

Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.

Detailed Description

In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks. This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Brain Stem Glioma

Keywords

DIPG, Hypofractionated Radiotherapy, Radiotherapy, Median survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated arm

Arm Type

Experimental

Arm Description

Arm Title

Conventional arm

Arm Type

Other

Arm Description

The same planning and treatment procedures will be performed with the established conventional regimen: 54 Gy in 30 fractions giving 1.8 Gy per fraction.

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated radiotherapy

Intervention Description

A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week

Intervention Type

Radiation

Intervention Name(s)

Conventional arm

Intervention Description

A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.

Primary Outcome Measure Information:

Title

Median overall-free survival

Time Frame

3 years

Title

Progression-free survival

Time Frame

3 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol. Patients were required to 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. The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast in three series, as well as diffusion imaging. Symptoms & signs of less than 3 months duration Exclusion Criteria: Children were not eligible if they had received any prior therapy other than steroid The diagnosis of exophytic brainstem glioma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed s zaghloul, MD

Organizational Affiliation

Children's Cancer Hospital Egypt 57357

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Cancer Hospital Egypt 57357

City

Cairo

ZIP/Postal Code

11441

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

24560760

Citation

Zaghloul MS, Eldebawy E, Ahmed S, Mousa AG, Amin A, Refaat A, Zaky I, Elkhateeb N, Sabry M. Hypofractionated conformal radiotherapy for pediatric diffuse intrinsic pontine glioma (DIPG): a randomized controlled trial. Radiother Oncol. 2014 Apr;111(1):35-40. doi: 10.1016/j.radonc.2014.01.013. Epub 2014 Feb 20.

Results Reference

derived

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Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

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