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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | 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 | |
| Progression-free survival | 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed s zaghloul, MD | Children's Cancer Hospital Egypt 57357 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Cancer Hospital Egypt 57357 | Cairo | 11441 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24560760 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 3, 2016 | |
| Reset | Feb 1, 2016 | |
| Release | Feb 3, 2016 | |
| Reset | Mar 2, 2016 | |
| Release | Jul 18, 2022 | |
| Reset | May 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2016 | Feb 1, 2016 | |||
| Feb 3, 2016 |
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Conventional arm | Radiation | A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction. |
|
| Mar 2, 2016 |
| Jul 18, 2022 | May 22, 2023 |