Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
NCT ID: NCT02013297
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2013-12-03
2021-10-12
Brief Summary
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Detailed Description
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For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :
* Few primary or secondary brain tumors, which cannot be surgically removed
* Spinal tumors
* Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth and controled primary tumor.
For pediatrics patients, no indication is now validated by HAS. Indications validated for adults are rare in pediatrics but not exceptional, and in such cases efficient alternative treatments does not exist.
In consequence, and regarding the good results obtained in adult patients, it seems very important to validate the efficacy of this treatment on pediatrics population
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SBRT treatment
According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
SBRT treatment
For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.
For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.
For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.
For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.
For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy.
Interventions
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SBRT treatment
For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.
For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.
For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.
For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.
For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Months
20 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Line CLAUDE, Doctor
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Antoine Lacassagne
Nice, Alpes Maritimes, France
Centre Paul Strauss
Strasbourg, Bas-Rhin, France
Hôpital La Timone
Marseille, Bouches Du Rhône, France
Centre François Baclesse
Caen, Calvados, France
CHU Bordeaux - Hôpital Saint André
Bordeaux, Gironde, France
Centre Claudius Régaud
Toulouse, Haute Garonne, France
Institut de Cancérologie de Montpellier
Montpellier, Hérault, France
Centre Eugène Marquis
Rennes, Ille Et Vilaine, France
CHRU de Tours - Hôpital Bretonneau
Tours, Indre Et Loire, France
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, Loire Atlantique, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe Et Moselle, France
Centre Oscar Lambret
Lille, Nord, France
Centre Léon Bérard
Lyon, Rhône, France
Institut Gustave Roussy
Villejuif, Val De Marne, France
Institut Curie
Paris, Île-de-France Region, France
Countries
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References
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Timmerman 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.
Rapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.
Rapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.
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Minniti 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.
Torok 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.
Zacharoulis 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.
Kano 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.
Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.
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Grabb PA, Lunsford LD, Albright AL, Kondziolka D, Flickinger JC. Stereotactic radiosurgery for glial neoplasms of childhood. Neurosurgery. 1996 Apr;38(4):696-701; discussion 701-2.
Hodgson DC, Goumnerova LC, Loeffler JS, Dutton S, Black PM, Alexander E 3rd, Xu R, Kooy H, Silver B, Tarbell NJ. Radiosurgery in the management of pediatric brain tumors. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):929-35. doi: 10.1016/s0360-3016(01)01518-8.
Chawla S, Schell MC, Milano MT. Stereotactic body radiation for the spine: a review. Am J Clin Oncol. 2013 Dec;36(6):630-6. doi: 10.1097/COC.0b013e31822dfd71.
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Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143.
Fogh SE, Andrews DW, Glass J, Curran W, Glass C, Champ C, Evans JJ, Hyslop T, Pequignot E, Downes B, Comber E, Maltenfort M, Dicker AP, Werner-Wasik M. Hypofractionated stereotactic radiation therapy: an effective therapy for recurrent high-grade gliomas. J Clin Oncol. 2010 Jun 20;28(18):3048-53. doi: 10.1200/JCO.2009.25.6941. Epub 2010 May 17.
Flannery T, Kano H, Martin JJ, Niranjan A, Flickinger JC, Lunsford LD, Kondziolka D. Boost radiosurgery as a strategy after failure of initial management of pediatric primitive neuroectodermal tumors. J Neurosurg Pediatr. 2009 Mar;3(3):205-10. doi: 10.3171/2008.11.PEDS08268.
Conter C, Carrie C, Bernier V, Geoffray A, Pagnier A, Gentet JC, Lellouch-Tubiana A, Chabaud S, Frappaz D. Intracranial ependymomas in children: society of pediatric oncology experience with postoperative hyperfractionated local radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1536-42. doi: 10.1016/j.ijrobp.2008.09.051. Epub 2009 Apr 11.
Massimino M, Gandola L, Giangaspero F, Sandri A, Valagussa P, Perilongo G, Garre ML, Ricardi U, Forni M, Genitori L, Scarzello G, Spreafico F, Barra S, Mascarin M, Pollo B, Gardiman M, Cama A, Navarria P, Brisigotti M, Collini P, Balter R, Fidani P, Stefanelli M, Burnelli R, Potepan P, Podda M, Sotti G, Madon E; AIEOP Pediatric Neuro-Oncology Group. Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di Ematologia-Oncologia Pediatrica) study. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45. doi: 10.1016/j.ijrobp.2003.08.030.
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Other Identifiers
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SBRT
Identifier Type: -
Identifier Source: org_study_id
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