- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777633
Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Although DIPG is not curable, re-irradiation with a modest total dose and short treatment time provides good palliation of symptoms, improves quality of life, delays disease progression and has minimal and manageable toxicity.
Treatment plan:
At progression, full radiological and clinical documentation necessary including a neurological exam by a neurologist will be done. Progressive patients will be referred to radiotherapy.
Radiation guidelines:
30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed. Radiation will be done in standard accelerators and according to standard guidelines used in treatment for all brain tumor patients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel, 91120
- Hadassah Medical Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age:1 year-22 years
- Patient/parent consent
- Diagnosis of DIPG based on short classic history, clinical signs (long tract signs, cranial nerve deficits and ataxia) and classic MRI features (more than 2/3 of the tumor is located within the pons and tumor encompasses more than 60% of the pons)
- A patient will be eligible for reirradiation if progression is diagnosed following a period of at least 4 months of stable disease after first irradiation.
- Progression may be either clinical (new neurological deficit or worsening of an old deficit in two separate physical examinations) or radiological (tumor growth of >25%)
Exclusion Criteria:
- Radiation necrosis post first irradiation
- Unstable vital signs
- Less than X months since previous irradiation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: re-irradiation
re-irradiation for progressive DIPG in children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delaying disease progression
Time Frame: 1 year
|
clinical progression: close follow up including biweekly neurological assessments to evaluate for clinical progression. any onset of a new neurological deficit or deterioration of an existing deficit will require follow up within one week. persistent deficit will be considered clinical progression. progression on imaging: MRI will be done every 3 months. tumor growth of >25% will be considered disease progression |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improving symptoms
Time Frame: 1 year
|
parents will report daily ADL (Activities of Daily Living), brainstem functions including double vision, voice, swallowing functions and facial nerve palsy.
parents will also report motor functions of the child in the biweekly visits.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Stem Neoplasms
- Infratentorial Neoplasms
- Glioma
- Brain Neoplasms
- Diffuse Intrinsic Pontine Glioma
Other Study ID Numbers
- 027812-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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