Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)

NCT02013297 | Completed DMC

• 1 other identifier: SBRT
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Brain Metastasis; Spinal Tumors; Lung Tumors; Ependymoma

Keywords

Pediatrics; SBRT; Brain metastasis; Pulmonary metastasis; Spinal metastasis; Pulmonary primary tumor; Spinal primary tumor; Relapsed ependymoma; Relapsed irradiated tumors; Local control rate; Safety; Overall survival; Progression Free Survival

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Efficacy of SBRT assessed between 1,5 and 3 months after treatment

  Between 1,5 and 3 months after inclusion

• Progressive Free Survival

  From the date of inclusion to the date of progression

• Overall Survival

  From the date of inclusion to the date of death (Up to 5 years since the first inclusion)

• Short time Safety profile of SBRT

  From inclusion to 3 months after inclusion

• Long term Safety profile of SBRT

  after 24 months after inclusion

Other Outcomes (4)

• SBRT treatment and toxicities related costs for 6 months after SBRT

  6 months after inclusion

• Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment

  6 months after inclusion

• Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment

  12 months after inclusion

Study Arms (1)

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

Radiation: SBRT treatment

Interventions

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.

SBRT treatment

Eligibility Criteria

• Age: 18 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (15)

Centre Antoine Lacassagne

Nice, Alpes Maritimes, 06050, France

Location

Centre Paul Strauss

Strasbourg, Bas-Rhin, 67805, France

Location

Hôpital La Timone

Marseille, Bouches Du Rhône, 13500, France

Location

Centre François Baclesse

Caen, Calvados, 14000, France

Location

CHU Bordeaux - Hôpital Saint André

Bordeaux, Gironde, 33000, France

Location

Centre Claudius Régaud

Toulouse, Haute Garonne, 31052, France

Location

Institut de Cancérologie de Montpellier

Montpellier, Hérault, 34298, France

Location

Centre Eugène Marquis

Rennes, Ille Et Vilaine, 35062, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, Indre Et Loire, 37044, France

Location

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, Loire Atlantique, 44805, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, France

Location

Centre Oscar Lambret

Lille, Nord, 59020, France

Location

Centre Léon Bérard

Lyon, Rhône, 69373, France

Location

Institut Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

Institut Curie

Paris, Île-de-France Region, 75231, France

Location

Related Publications (22)

• 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.

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• 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.

  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.

  PMID: 21528665 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.

  PMID: 21052773 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.

  PMID: 21517131 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.

  PMID: 20039045 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.

  PMID: 21039163 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.

  PMID: 19260098 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.

  PMID: 17854490 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.

  PMID: 15558704 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.

  PMID: 8692387 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.

  PMID: 11429220 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.

  PMID: 22134513 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.

  PMID: 20423672 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.

  PMID: 20479693 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.

  PMID: 20479391 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.

  PMID: 19338466 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.

  PMID: 19362789 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.

  PMID: 15050308 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.

  PMID: 18981883 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.

  PMID: 18406885 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Spinal Cord Neoplasms; Lung Neoplasms; Ependymoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Line CLAUDE, Doctor

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 17, 2013
• Study Start: December 3, 2013
• Primary Completion: April 3, 2020
• Study Completion: October 12, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

FR (15)