Trials / Completed
CompletedNCT01878266
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Children's Cancer Hospital Egypt 57357 · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Hypofractionated Arm (1) | A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week |
| RADIATION | Hypofractionated Arm (2) | The total dose to 4500 cGy in 15 fractions in 3 weeks |
| RADIATION | Conventional Arm (3) | A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2013-06-14
- Last updated
- 2021-08-09
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT01878266. Inclusion in this directory is not an endorsement.