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

NCT ID: NCT01777633

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-02-28

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.

Conditions

Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

re-irradiation

re-irradiation for progressive DIPG in children

Group Type: EXPERIMENTAL

Palliative re-irradiation for progressive DIPG in children

Intervention Type: RADIATION

Interventions

Palliative re-irradiation for progressive DIPG in children

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age:1 year-22 years

2. Patient/parent consent

3. 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)

4. 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.

5. 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

1. Radiation necrosis post first irradiation

2. Unstable vital signs

3. Less than X months since previous irradiation

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

027812-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id