Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population … (NCT02013297) | Clinical Trial Compass
CompletedNot Applicable
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
France61 participantsStarted 2013-12-03
Plain-language summary
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
Who can participate
Age range18 Months – 20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 and patient
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 evalu…
What they're measuring
1
Efficacy of SBRT assessed 6 months after treatment