ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01635140
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357

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.

Condition or disease Intervention/treatment Phase
Pediatric Brain Stem Glioma Radiation: Hypofractionated radiotherapy Radiation: Conventional arm Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
Study Start Date : May 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypofractionated arm
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
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week

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




Primary Outcome Measures :
  1. Median overall-free survival [ Time Frame: 3 years ]
  2. Progression-free survival [ Time Frame: 3 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
  2. 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.
  3. No performance criteria were required for entry onto the study.
  4. 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.
  5. Symptoms & signs of less than 3 months duration

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635140


Locations
Egypt
Children's Cancer Hospital Egypt 57357
Cairo, Egypt, 11441
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
Principal Investigator: Mohamed s zaghloul, MD Children's Cancer Hospital Egypt 57357

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01635140     History of Changes
Other Study ID Numbers: CCHE-BT001
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by Children's Cancer Hospital Egypt 57357:
DIPG
Hypofractionated Radiotherapy
Radiotherapy
Median survival

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue