Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
|ClinicalTrials.gov Identifier: NCT01777633|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : April 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma||Radiation: Palliative re-irradiation for progressive DIPG in children||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
re-irradiation for progressive DIPG in children
|Radiation: Palliative re-irradiation for progressive DIPG in children|
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777633
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|