Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
NCT ID: NCT01878266
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2013-02-28
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated Arm (1)
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 (1)
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
Hypofractionated Arm (2)
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.
Hypofractionated Arm (2)
The total dose to 4500 cGy in 15 fractions in 3 weeks
Conventional Arm (3)
The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.
Conventional Arm (3)
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
Interventions
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Hypofractionated Arm (1)
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
Hypofractionated Arm (2)
The total dose to 4500 cGy in 15 fractions in 3 weeks
Conventional Arm (3)
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
Eligibility Criteria
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Inclusion Criteria
2. Aged 2-18years,
3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
4. No performance criteria were required for entry onto the study.
Exclusion Criteria
2 Years
18 Years
ALL
No
Sponsors
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Children's Cancer Hospital Egypt 57357
OTHER
Responsible Party
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Locations
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Children's Cancer Hospital Egypt 57357
Cairo, , Egypt
Countries
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Other Identifiers
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CCHE-BT002
Identifier Type: -
Identifier Source: org_study_id
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