Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
NCT ID: NCT01635140
Last Updated: 2012-07-09
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
PHASE3
64 participants
INTERVENTIONAL
2010-05-31
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
Conventional arm
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Interventions
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Hypofractionated radiotherapy
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
Conventional arm
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Eligibility Criteria
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Inclusion Criteria
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
2. The diagnosis of exophytic brainstem glioma
3 Years
18 Years
ALL
No
Sponsors
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Children's Cancer Hospital Egypt 57357
OTHER
Responsible Party
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Principal Investigators
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Mohamed s zaghloul, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Cancer Hospital Egypt 57357
Locations
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Children's Cancer Hospital Egypt 57357
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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CCHE-BT001
Identifier Type: -
Identifier Source: org_study_id