Pediatric Brain Stem GliomaPhase 3NCT01635140
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
A Phase 3 study testing Hypofractionated radiotherapy and Conventional arm in people with Pediatric Brain Stem Glioma, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Brain Stem Glioma
- What is being tested?
- Hypofractionated radiotherapy and Conventional arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- May 2010to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
- 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.
- No performance criteria were required for entry onto the study.
- 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.
- Symptoms \& signs of less than 3 months duration
Who cannot join
- Children were not eligible if they had received any prior therapy other than steroid
- The diagnosis of exophytic brainstem glioma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.
Read the detailed description
In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.
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
- Pediatric Brain Stem Glioma
- Being tested
- Hypofractionated radiotherapy, Conventional arm
- Keywords
- DIPG, Hypofractionated Radiotherapy, Radiotherapy, Median survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
Conventional armRadiation
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated arm | Experimental | 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 Receives: Radiation: Hypofractionated radiotherapy |
| Conventional arm | Other | 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. Receives: Radiation: Conventional arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median overall-free survival
Measured: 3 years
Progression-free survival
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Brain Stem GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed s zaghloul, MD, Principal investigator, Children's Cancer Hospital Egypt 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635140
- Sponsor's protocol ID
- CCHE-BT001
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24560760
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
- ClinicalTrials.gov ID
- NCT01635140
- Acronym / sponsor ID
- CCHE-BT001
- Conditions
- Pediatric Brain Stem Glioma
- Keywords
- DIPG, Hypofractionated Radiotherapy, Radiotherapy, Median survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.
Detailed description
In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated arm | Experimental | Radiation: Hypofractionated radiotherapyA 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 |
| Conventional arm | Other | Radiation: Conventional armThe same planning and treatment procedures will be performed with the established conventional regimen: 54 Gy in 30 fractions giving 1.8 Gy per fraction. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
- 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.
- No performance criteria were required for entry onto the study.
- 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.
- Symptoms \& signs of less than 3 months duration
Key exclusion criteria (2 listed)
- Children were not eligible if they had received any prior therapy other than steroid
- The diagnosis of exophytic brainstem glioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapyA total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week | Radiation | Hypofractionated arm |
| Conventional armA total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction. | Radiation | Conventional arm |
Primary outcome
Median overall-free survival
Time frame: 3 years
Progression-free survival
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Derived from this study: PubMed 24560760Zaghloul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed s zaghloul, MD principal investigator
Children's Cancer Hospital Egypt 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionated radiotherapy and Conventional arm in people with Pediatric Brain Stem Glioma, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median overall-free survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.