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.
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.
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.
Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma
Radiation: Palliative re-irradiation for progressive DIPG in children
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children|
- delaying disease progression [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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
- improving symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2020 (Final data collection date for primary outcome measure)|
re-irradiation for progressive DIPG in children
|Radiation: Palliative re-irradiation for progressive DIPG in children|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777633
|Contact: Hadas Lemberg, PhD||00 972 2 firstname.lastname@example.org|
|Hadassah Medical Organization||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Iris Freid, M.D.|