NCT01635140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
Last Updated

July 9, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

June 28, 2012

Last Update Submit

July 6, 2012

Conditions

Pediatric Brain Stem Glioma

Keywords

DIPGHypofractionated RadiotherapyRadiotherapyMedian survival

Outcome Measures

Primary Outcomes (2)

  • Median overall-free survival

    3 years

  • Progression-free survival

    3 Years

Study Arms (2)

Hypofractionated arm

EXPERIMENTAL

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

Radiation: Hypofractionated radiotherapy

Conventional arm

OTHER

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.

Radiation: Conventional arm

Interventions

Hypofractionated radiotherapyRADIATION

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

Hypofractionated arm
Conventional armRADIATION

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

Conventional arm

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 24560760DERIVED

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Mohamed s zaghloul, MD

    Children's Cancer Hospital Egypt 57357

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 9, 2012

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 9, 2012

Record last verified: 2012-07

Locations

EG(1)