Clinical trial · Interventional
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
NCT02013297CI-TRIAL-00056945SBRTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | — | UNRESOLVED | — |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Lung Tumors | Lung Neoplasm | ALIAS | 0.90 |
| Spinal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT treatment
- description
- According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
- interventionNames
- Radiation: SBRT treatment
Primary outcomes (1)
- measure
- Efficacy of SBRT assessed 6 months after treatment
- timeFrame
- 6 months after inclusion
- description
- The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
Secondary outcomes (8)
- measure
- Efficacy of SBRT assessed between 1,5 and 3 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 20 Years
Show eligibility criteria text
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 evaluable target (except for completely resected ependymomas) * 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
References
Publications (22)
- BACKGROUNDTimmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available. PMID 18725106
- BACKGROUNDRapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.
- BACKGROUNDRapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.
- BACKGROUNDMaranzano E, Anselmo P, Casale M, Trippa F, Carletti S, Principi M, Loreti F, Italiani M, Caserta C, Giorgi C. Treatment of recurrent glioblastoma with stereotactic radiotherapy: long-term results of a mono-institutional trial. Tumori. 2011 Jan-Feb;97(1):56-61. doi: 10.1177/030089161109700111. PMID 21528665
- BACKGROUNDMinniti G, Armosini V, Salvati M, Lanzetta G, Caporello P, Mei M, Osti MF, Maurizi RE. Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma. J Neurooncol. 2011 Jul;103(3):683-91. doi: 10.1007/s11060-010-0446-8. Epub 2010 Nov 5. PMID 21052773
- BACKGROUNDTorok JA, Wegner RE, Mintz AH, Heron DE, Burton SA. Re-irradiation with radiosurgery for recurrent glioblastoma multiforme. Technol Cancer Res Treat. 2011 Jun;10(3):253-8. doi: 10.7785/tcrt.2012.500200. PMID 21517131
- BACKGROUNDZacharoulis S, Ashley S, Moreno L, Gentet JC, Massimino M, Frappaz D. Treatment and outcome of children with relapsed ependymoma: a multi-institutional retrospective analysis. Childs Nerv Syst. 2010 Jul;26(7):905-11. doi: 10.1007/s00381-009-1067-4. Epub 2009 Dec 29. PMID 20039045
- BACKGROUNDKano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr. 2010 Nov;6(5):417-23. doi: 10.3171/2010.8.PEDS10252.