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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Arm (1) | 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 |
|
| Hypofractionated Arm (2) | Experimental | 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. |
|
| Conventional Arm (3) | Other | The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Arm (1) | Radiation | A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median overall-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Cancer Hospital Egypt 57357 | Cairo | 11441 | Egypt |
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| Hypofractionated Arm (2) | Radiation | The total dose to 4500 cGy in 15 fractions in 3 weeks |
|
| Conventional Arm (3) | Radiation | A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm |
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| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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