Clinical Trial: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children

Brief Summary:

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.


Detailed Summary:
Sponsor: Hadassah Medical Organization

Current Primary Outcome: 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



Original Primary Outcome: delaying disease progression [ Time Frame: 1 year ]

clinical progression: close follow up including biweekly neurological assesments 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 dosease progression



Current Secondary Outcome: 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.


Original Secondary Outcome: improving symptoms [ Time Frame: 1 year ]

parents will report daily ADL , 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.


Information By: Hadassah Medical Organization

Dates:
Date Received: January 13, 2013
Date Started: February 2013
Date Completion:
Last Updated: April 19, 2015
Last Verified: December 2012