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POTENTIAL INDICATIONS OF HADRONTHERAPY IN THE SARCOMAS ANALYSIS OF THE LITERATURE

POTENTIAL INDICATIONS OF HADRONTHERAPY IN THE SARCOMAS ANALYSIS OF THE LITERATURE. Dr Marie Pierre SUNYACH Dr Pascal POMMIER Centre Léon Bérard Dr Emmanuel AMSELLEM Faculté Laënnec Lyon, France. Carbon Ions - Perspective. Rationnal Balistic Bragg peak Biological

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POTENTIAL INDICATIONS OF HADRONTHERAPY IN THE SARCOMAS ANALYSIS OF THE LITERATURE

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  1. POTENTIAL INDICATIONS OF HADRONTHERAPY IN THE SARCOMAS ANALYSIS OF THE LITERATURE Dr Marie Pierre SUNYACH Dr Pascal POMMIER Centre Léon Bérard Dr Emmanuel AMSELLEM Faculté Laënnec Lyon, France

  2. Carbon Ions - Perspective • Rationnal • Balistic • Bragg peak • Biological • 2 to 3 times more efficient than photon From GSI, Darmstadt, Germany

  3. Hadrontherapy Centers (Carbon Ions) • Existing Centers • 1994: National Institute for Radiological Science (Japan) • 1997: GSI, Darmstadt (Germany) • 2001: Hyogo Ion Beam Medical Center (Japan) • In development (Europe) • Germany (Heidelberg) • Italia (CNAO – TERA, Pavi) • Austria (Medaustron, Baden –Vienna) • France (ETOILE, Lyon)

  4. The Medical Project • The «medical project » • Determine the potential indications of carbon ions. • First tumor types studied • Head and neck • Sarcoma • Glioma

  5. Objectives • To define the situations in which an increased dose (using carbon ions) could be efficient • To define the survival and local control expected when the « best treatment » is used • To evaluate the risk of toxicities • This is not an exhaustive review of litterature

  6. Definitionof the best treatment • Established treatments • Treatments assessed by randomized studies • Standard treatments • Treatment established by consensus • Innovative treatments • Treatments with no validation  No Established treatments for those indications

  7. 2002 - 2003 • The potential indications tables • Indications (topo, stage, pathology..) • Standard and concurrent therapies Local Working Groups Screening of all topographies and histologies to identify a priori any potential indication for Hadrontherapy 2003 – 2006 “Evidence based medicine” approach (methodologists) screening and analysis of all relevant literature (HT & conc. Therapies) “Epidemiological landscape” Cancer registry (FRANCIM) and “One day survey” in French radiation oncology departments International experts 2003 – 2006 A portfolio of multicenter clinical trials - Validation of the indications for HT (P. and/or C) - Estimation of the therapeutic gain & priorities - Prospective trials Clinical Trial n° 1 for hadronthérapie zegqergqeomfhmlqejheqùtjheqojhoqejthùojetùphjùqsetophjpqejthoqjethùjqetùhjqùptjohùqrotjhùpqtjhopjqtpohjqeùthjùpotjhopqtjhopsjthpojsrthojqùpetohjqopetjhqopetjhqopejthqopejthopqejthopjqethopjqùpetohjùpqojhqojethpoqjethojqùpetohjqùpeotjhùqopetjhopqejthùopqjehopjqethjoqùpoerjghùpqrjghiùohjrgklfhlihbjljhbjhoej

  8. Table of potential indications

  9. Plan • Soft tissue sarcoma R1 and R2 • Osteosarcoma and Chondrosarcoma • Skull base Chondrosarcoma and Chordoma

  10. STS: 1524 identified references 21 analysed in the final document 1524References 135selectionnated • 1389Exclusions (abstract) : • Language • No indication about • treatments • Review:Nb of pts < 10 • Publication before 1970 • Children • Animals • Resction R0 21definitively selectionnated • 114Exclusions (article) • No clinical data • Resection R0 • No RTE • RTE < 50 Gy • Nb < 10 pts • No indication • about treatment • Dosimetric studies

  11. STS R1 (extremity or axial)

  12. STS R1: proposition R1 definitive and never resectable • Hadrontherapy will not replaced good surgery • Objective of Carbon Ions  To decrease local recurrence to near 0 % Non randomized phase II

  13. STS R2 / unresecable (extremity /axial)

  14. STS R2 or unresecable proposition • R2 definitive and never resecable  Hadrontherapy will not replaced good surgery • Non randomized phase II trial • Photontherapy : • LC 10 % • Neutrontherapy : • LC 60% •  Objective : at least 50% local control with few toxicities • Unresecable tumor or recurrence with oligo metastasis can be treated in this group

  15. RetroperitonalSTS

  16. Retroperitonal STSProposition • Post-operative irradiation is not a standard treatment • Improving local control is needed • Non randomized Phase II for R2 or unresecable tumor.

  17. Osteosarcoma, Chondrosarcoma (Limbs or Sacrum):1635 identified references 11 analysed in the final document 1635 References 114 selectionnated • 1521Exclusions (abstract): • Langage • No indication • about treatment • Review: Nb of pts < 10 • Publication before 1970 • 103Exclusions (article): • No clinical data • Resection R0 • No RTE • RTE < 50 Gy • Nb < 10 pts • No indication • about treatment 11 definitively selectionnated

  18. Chondrosarcoma R2 or unresecable

  19. R2 or unresecable Osteosarcoma

  20. R2 or Unresectable Osteosarcoma and Chondrosarcoma: Proposition • Phase II Stratification according to histology and tumor grade • Unresecable tumor or recurrence with oligo metastasis can be treated in this group

  21. Chordoma of the skull base, Chondrosarcoma of the Skull base:1077 identified references 19 analysed in the final document 1077 References 119selectionnated • 958 Exclusions (abstract): • Language • No indication • about treatment • Review: Nb of pts < 10 • Publication before 1970 19definitively selectionnated • 100Exclusions (article): • No clinical data • Resection R0 • No RTE • RTE < 50 Gy • Nb < 10 pts • No indication • about treatment

  22. Skull Base Chordoma

  23. Skull Base Chondrosarcoma

  24. Chordoma (Spine or Sacrum)

  25. Skull of base Chordoma and Chondrosarcoma • Skull Base Chordoma • Encouraging Local Control • Phase II randomized Study: Proton/Carbon • Skull Base Chondrosarcoma • Association surgery and protontherapy • Excellent results • This is not an indication for Carbon ions • Excepted for large tumor volume

  26. Summary • Difficulty to assess the efficiency of standard treatments to be compared with carbon ions • Small studies • Few homogenous series of patients treated with adequate doses of radiation therapy • Survival data not reported by subgroup of treatments

  27. Indications

  28. Physic rationnal Pic de Bragg Protons, lightions Pic de Bragg étalé

  29. Objectif: projet médical français et européen* commun pour l’hadronthérapie (protons – carbone) Principes: Multidisciplinarité (oncologues , chirurgiens, spécialistes d’organes, anapaths, épidémiologistes, ..) Fondée sur une analyse rigoureuse de la littérature et l’avis d’experts indépendants * ENLIGHT  ERANET Projet médical « Hadronthérapie »

  30. Schema of the analysis of literatture • To do the synthesis of literature in selectionnated situations • To define the survival and local control expected when the « best treatment » is used • This is not an exhaustive review of litterature • To present this document to a group of experts • Validation of the potential indications • Stratification of those indications • To define the modality of evaluation

  31. List of clinical situations to be evaluated Report sudmitted to a group of experts Studies research : type of tumors type of treatments charateristic of studies Medline Cochrane data base institutionnal websites Referencemanager Selection of studies Definitive list of potential indications • summary • integral text Document

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