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 range

18 Months – 20 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of SBRT assessed 6 months after treatment

Timeframe: 6 months after inclusion

Trial details

NCT IDNCT02013297

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-03

View on ClinicalTrials.gov More Brain Metastasis trials

Who can participate

Age range

18 Months – 20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.