Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
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|ClinicalTrials.gov Identifier: NCT01635140|
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : July 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Brain Stem Glioma||Radiation: Hypofractionated radiotherapy Radiation: Conventional arm||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- Median overall-free survival [ Time Frame: 3 years ]
- Progression-free survival [ Time Frame: 3 Years ]
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
|Children's Cancer Hospital Egypt 57357|
|Cairo, Egypt, 11441|
|Principal Investigator:||Mohamed s zaghloul, MD||Children's Cancer Hospital Egypt 57357|