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The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the delivery of a single high dose radiation treatment or a few fractionated radiation treatments (usually up to 5). A high potent biological dose of radiation is delivered to the tumor improving the cure rates for the tumor, in a manner previously not achievable by standard conventional radiation therapy.
For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT treatment | Experimental | According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT treatment | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of SBRT assessed 6 months after treatment | 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) | 6 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of SBRT assessed between 1,5 and 3 months after treatment | The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) between 1,5 and 3 months after treatment | Between 1,5 and 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| SBRT treatment and toxicities related costs for 6 months after SBRT | The SBRT treatment related costs will be evaluated by a "microcosting" method which take into account, in particular, the irradiation duration seance, the time for the mobilized staff, the kind of equipment required, the duration of related AE hospitalizations. | 6 months after inclusion |
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
Affiliation to a social security scheme
Signed Informed consent by patient or parents and patient
IN ADDITION FOR RELAPSING EPENDYMOMA:
NON-INCLUSION CRITERIA :
IN ADDITION FOR RELAPSING EPENDYMOMAS:
NON-RANDOMIZATION DOSIMETRIC CRITERIA (ONLY FOR EPENDYMOMA)
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| Name | Affiliation | Role |
|---|---|---|
| Line CLAUDE, Doctor | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | Alpes Maritimes | 06050 | France | ||
| Centre Paul Strauss |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18725106 | Background | 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. | |
| Background | Rapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000. | ||
| Background | Rapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006. | ||
| 21528665 |
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|
| Progressive Free Survival | Calculated from the date of inclusion to the date defined as the first documented disease progression, or second cancer appearance, or death from any cause (Up to 5 years since the first inclusion) | From the date of inclusion to the date of progression |
| Overall Survival | Calculated from the date of inclusion to the date of death from any cause (Up to 5 years since the first inclusion) | From the date of inclusion to the date of death (Up to 5 years since the first inclusion) |
| Short time Safety profile of SBRT | Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | From inclusion to 3 months after inclusion |
| Long term Safety profile of SBRT | Toxicities appeared after 24 months after inclusion. The outcome measure concerns toxicities appeared after the study following period. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | after 24 months after inclusion |
| Efficacy of SBRT assessed 12 months after treatment | The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 12 months after treatment | 12 months after inclusion |
| Efficacy of SBRT assessed 24 months after treatment | The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 24 months after treatment | 24 months after inclusion |
| Medium time Safety profile of SBRT | Toxicities appeared between 3 months and 24 months after treatment. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Between 3 months and 24 months after inclusion |
| Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment | 2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated the cost/efficacity ratio for the avoided toxicity 6 months after SBRT. The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts | 6 months after inclusion |
| Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment | 2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :
The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts | 12 months after inclusion |
| Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment | 2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :
The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts | 24 months after inclusion |
| Strasbourg |
| Bas-Rhin |
| 67805 |
| France |
| Hôpital La Timone | Marseille | Bouches Du Rhône | 13500 | France |
| Centre François Baclesse | Caen | Calvados | 14000 | France |
| CHU Bordeaux - Hôpital Saint André | Bordeaux | Gironde | 33000 | France |
| Centre Claudius Régaud | Toulouse | Haute Garonne | 31052 | France |
| Institut de Cancérologie de Montpellier | Montpellier | Hérault | 34298 | France |
| Centre Eugène Marquis | Rennes | Ille Et Vilaine | 35062 | France |
| CHRU de Tours - Hôpital Bretonneau | Tours | Indre Et Loire | 37044 | France |
| Institut de Cancérologie de l'Ouest René Gauducheau | Saint-Herblain | Loire Atlantique | 44805 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | Meurthe Et Moselle | 54511 | France |
| Centre Oscar Lambret | Lille | Nord | 59020 | France |
| Centre Léon Bérard | Lyon | Rhône | 69373 | France |
| Institut Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| Institut Curie | Paris | ÃŽle-de-France Region | 75231 | France |
| Background |
| Maranzano 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. |
| 21052773 | Background | 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. |
| 21517131 | Background | 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. |
| 20039045 | Background | 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. |
| 21039163 | Background | 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. |
| 19260098 | Background | 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. |
| 17854490 | Background | Combs SE, Behnisch W, Kulozik AE, Huber PE, Debus J, Schulz-Ertner D. Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma. BMC Cancer. 2007 Sep 13;7:177. doi: 10.1186/1471-2407-7-177. |
| 15558704 | Background | Giller CA, Berger BD, Pistenmaa DA, Sklar F, Weprin B, Shapiro K, Winick N, Mulne AF, Delp JL, Gilio JP, Gall KP, Dicke KA, Swift D, Sacco D, Harris-Henderson K, Bowers D. Robotically guided radiosurgery for children. Pediatr Blood Cancer. 2005 Sep;45(3):304-10. doi: 10.1002/pbc.20267. |
| 8692387 | Background | 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. |
| 11429220 | Background | 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. |
| 22134513 | Background | 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. |
| 20423672 | Background | Lo SS, Sahgal A, Wang JZ, Mayr NA, Sloan A, Mendel E, Chang EL. Stereotactic body radiation therapy for spinal metastases. Discov Med. 2010 Apr;9(47):289-96. |
| 20479693 | Background | 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. |
| 20479391 | Background | 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. |
| 19338466 | Background | 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. |
| 19362789 | Background | 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. |
| 15050308 | Background | 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. |
| 18981883 | Background | Sharma MS, Kondziolka D, Khan A, Kano H, Niranjan A, Flickinger JC, Lunsford LD. Radiation tolerance limits of the brainstem. Neurosurgery. 2008 Oct;63(4):728-32; discussion 732-3. doi: 10.1227/01.NEU.0000325726.72815.22. |
| 18406885 | Background | Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037. |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D008175 | Lung Neoplasms |
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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