Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
1 other identifier
interventional
119
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 9, 2021
August 1, 2021
3.2 years
June 9, 2013
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median overall-free survival
3 years
Secondary Outcomes (1)
Progression-free survival
3 years
Study Arms (3)
Hypofractionated Arm (1)
EXPERIMENTALA 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)
EXPERIMENTALThe 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)
OTHERThe same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.
Interventions
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
The total dose to 4500 cGy in 15 fractions in 3 weeks
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
Eligibility Criteria
You may qualify if:
- Newly diagnosed patients with a diffuse intrinsic brainstem glioma
- Aged 2-18years,
- Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
- No performance criteria were required for entry onto the study.
You may not qualify if:
- Children were not eligible if they had received any prior therapy other than steroids Treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Cancer Hospital Egypt 57357
Cairo, 11441, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2013
First Posted
June 14, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 9, 2021
Record last verified: 2021-08