Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-04 @ 1:55 PM
Study NCT ID:
NCT01878266
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2013-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Sponsor:
Children's Cancer Hospital Egypt 57357
Organization:
Study Overview
Official Title:
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: