Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02013297 : Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
PhaseN/A
AgesMin: 18 Months Max: 20 Years
Eligibility
INCLUSION CRITERIA:

- 18 months = age = 20 years

- Malignant primary tumor, histologically or cytologically proven

- Systemic disease under control or with slow evolution

- Written indication of SBRT according to local pediatrics meeting and national
Radiotherapy (RT) web conference

- Performance Status = 2 according to Eastern Cooperative Oncology Group (ECOG)

- Sites

- Brain metastasis (= 3 on MRI) not suitable for surgery, without hemorrhage, less
than 3 cm each, not in the brain stem

- Primary or secondary spinal/para spinal metastasis (= 3), not suitable for
surgery or with a non operable macroscopic residue, less than 5 cm

- Lung metastasis (= 3), less than 5 cm, not eligible for surgery, or macroscopic
residue not suitable for surgery

- Previously irradiated relapsing isolated primitive/secondary tumor (intra cranial
or extra cranial), with no possible surgery, or macroscopic residue.

- Affiliation to a social security scheme

- Signed Informed consent by patient or parents.

IN ADDITION FOR RELAPSING EPENDYMOMA:

- Histologically proven local ependymoma at diagnosis

- Previously irradiated ependymoma

- Exclusive local relapse in previously irradiated site

- Review of operability at time of relapse by a multidisciplinary staff

- Relapse must be confirmed by a neuro-oncology multidisciplinary staff, on MRI
evolutivity characteristics

- Time to relapse after previous irradiation = 1 year

NON-INCLUSION CRITERIA :

- Concomitant chemotherapy

- No evaluable target

- Pregnancy

- Follow-up impossible

IN ADDITION FOR RELAPSING EPENDYMOMAS:

- Metastatic patient at diagnosis and/or at relapse

- Complete remission never obtained

NON-RANDOMIZATION DOSIMETRIC CRITERIA (ONLY FOR EPENDYMOMA)

- Cumulative doses to brain stem = 115 Gy

- Tumor volume at relapse = 30 cm3

- Primary RT dose + Re-irradiation dose more than 112 Gy

- Cumulative dose to the chiasma > 54 Gy

- Cumulative dose to any point of the brain > 115 Gy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02013297      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740