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Epssg NRSTS 2005 EpSSG NRSTS 2005 a protocol for Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas VERSION 1.1 SEPTEMBER 2009 EpSSG NRSTS 2005 protocol Version 1.1 Contents 1. Administrative organisation p. 3 1.1 Protocol sponsor p. 3 1.2 Protocol coordination p. 3 1.3 EpSSG and NRSTS 2005 structure p. 4 2. Abbreviations p.10 3. Summary p.11 3.1. Objectives p.12 3.2. Patients eligibility p.12 3.3. Patients stratification p.13 3.4. Pathology and Biology p.13 3.5. Statistical consideration p.13 3.6. Organisation of the study p.14 3.7. Datamanagement and analysis p.14 3.8. Ethical consideration p.14 4. Background p.16 4.1. References p.20 5. Study structure p.22 6. Patient eligibility p.22 7. Pre-treatment investigation p.23 7.1. Histological diagnosis p.23 7.2. Clinical assessment p.23 7.3. Laboratory investigations p.23 7.4. Radiological investigations p.24 7.5. Tumour measurements p.25 7.6. Lung lesions p.25 8. Staging system p.26 8.1. References p.26 9. Surgical guidelines p.27 9.1. Definitions p.27 9.2. Biopsy p.28 9.3. Primary resection p.29 9.4. Primary re-operation p.30 9.5. Secondary re-operation p.30 9.6. Reconstructive surgery and local control p.31 9.7. Lymph nodes p.31 9.8. Specific sites p.32 9.9. Surgery for relapse p.34 9.10. Marker clips p.34 9.11. Histology p.34 9.12. References p.34 10. Radiotherapy guidelines p.36 10.1. Equipment p.36 10.2. Treatment planning p.36 10.3. Fractionation p.37 10.4. Target volume definition for primary tumour p.37 10.5. Target volume definition for lymph nodes p.38 10.6. Timing of radiotherapy p.38 10.7. Indications and doses p.39 10.8. Normal tissue tolerance guidelines p.40 10.9. Treatment guidelines for special sites p.40 10.10. Quality assurance of radiotherapy p.41 10.11. References p.42 11. Chemotherapy guidelines p.43 1 EpSSG NRSTS 2005 protocol Version 1.1 11.1. Chemotherapy regimen p.44 11.2. Chemotherapy administration and drugs information p.45 11.3. Chemotherapy toxicity p.47 11.4. Supportive care p.49 11.5. References p.50 12. Investigations during and at the end of treatment p.52 12.1. Investigation during treatment p.52 12.2. Tumour reassessment p.52 12.3. Response evaluation criteria p.53 12.4. Investigations at the end of treatment p.53 12.5. Investigations during follow-up p.54 13. Synovial sarcoma p.56 13.1. Chemotherapy p.56 13.2. Radiotherapy p.60 13.3. Risk-adapted treatment program p.65 13.4. References p.67 14. Adult-type soft tissue sarcomas p.68 14.1. Chemotherapy p.68 14.2. Radiotherapy p.73 14.3. Risk-adapted treatment program p.76 14.4. References p.78 15. Statistical considerations p.79 16. Organisational and administrative issues p.82 Appendix p.87 TNM classification and grouping p.88 IRS clinical grouping classification p.90 Definition of sites p.92 Regional lymph nodes definition p.97 Toxicity grading p.98 Other histotypes p.103 1. Infantile fibrosarocoma p.103 2. Desmoplastic small round cell tumour p.106 3. Undifferentiated sarcoma of the liver p.108 4. Malignant ectomesencymoma p.109 5. Mesenchymal chondrosarocma p.110 6. Epithelioid hemangioendothelioma p.111 7. Myofibroblastic lesions and aggressive fibromatosis p.112 8. Extracranial rhabdoid tumour p.119 Second-line therapies p.148 Metastatic NRSTS p.154 Radiological guidelines p.155 Pathology guidelines p.164 Biological aspects p.186 Declaration of Helsinki p.189 Information sheet/consent forms p.192 2 EpSSG NRSTS 2005 protocol Version 1.1 1. Administrative organisation 1.1 Protocol Sponsor It is responsibility of each participating national Group or Institutions to arrange sponsorship in line with the requirements of the European Union directive on Good Clinical Practice in Clinical Trials. 1.2 Protocol Coordination The protocol is co-ordinated by a Trial Monitoring Committee under the supervision of European paediatric Soft Tissue Sarcoma Study Group (in its abbreviated form EpSSG) Board. EpSSG is a new collaborative structure. It was originally founded by the Co-operative Weichteilsarkom Studie (CWS), the AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC) (former ICG: Italian Cooperative Group for paediatric soft tissue sarcoma) and the SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT), that joined forces to design and implement a portfolio of pan-European studies addressed at children and adolescents affected by soft tissue sarcoma. The three cooperative Groups acted on behalf of the following Societies: GPOH - Gesellschaft für pädiatrische Onkologie und Hämatologie (Germany, Austria) AIEOP - Associazione Italiana di Ematologia e Oncologia Pediatrica (Italy) UKCCSG - United Kingdom Children‘s Cancer Study Group (United Kingdom) SFCE - Société Francaise des Cancers d’Enfants (France) SEOP - Sociedad Espanola de Oncologìa Pediátrica (Spain) NOPHO - Nordic Organisation of Pediatric Hematology and Oncology (Denmark, Norway, Sweden) DCOG – Dutch Childhood Oncology Group (The Netherlands) BSPHO - Belgian Society of Paediatric Hematology Oncology (Belgium) This study will not introduce or try to license chemotherapeutic agents for treatment of paediatric sarcoma. Treatment will rely on already licensed and introduced chemotherapeutic drugs. Therefore, chemotherapeutic agents and other therapeutic substances needed for treatment in EpSSG NRSTS 2005 will not be paid for by the study nor will these substances be provided by pharmaceutical companies. Important note: It is emphasised that no legal responsibility for possible consequences resulting from the application of recommendations from this protocol will be taken by the members of the EpSSG. Treatment and follow-up of patients with soft tissue sarcoma requires a high degree of medical competence and humane presence existing only in hospitals with adequate infra-structure. A state of emergency due to complications from the underlying disease or from its treatment can develop in every patient at any time. Children with soft tissue sarcomas should thus be treated by an experienced team with multidisciplinary competences. 3 EpSSG NRSTS 2005 protocol Version 1.1 1.3 EpSSG and NRSTS 2005 Structure EpSSG BOARD Prof. Michael Stevens Prof. Modesto Carli University of Bristol Haematology/Oncology Division Institute of Child Life and Health Department of Paediatric 6th Floor, UBHT Education Centre Via Giustiniani, 3 Upper Maudlin Street 35128 Padova, Italy Bristol BS2 8AE Tel +39 049 8213565 Tel +44 (0) 117 0205 Fax +39 049 8211462 E-mail: [email protected] E-mail: [email protected] Dr. Odile Oberlin Dr. Andrea Ferrari Paediatric Oncology Pediatric Oncology Unit, Institut Gustave Roussy Istituto Nazionale Tumori, Rue Camille Desmoulins Via G. Venezian 1, 20133 Milano, Italy 94805 Villejuif Cedex, France Tel +39 02 23902588 Tel +33-1-45 59 41 42 Fax +39 02 23902648 Fax +33-1-45 59 E-mail: [email protected] E-mail: [email protected] Dr. Gianni Bisogno Dr. Christophe Bergeron Haematology/Oncology Division Institut d’Hémato-Oncologie Pédiatrique (IHOP) Department of Paediatric, 28 rue Laennec, 69800 Lyon, France Via Giustiniani, 3 - 35128 Padova, Italy Tel 33 (0)4 78 78 26 06 Tel +39 049 8211481 Fax 33 (0)4 78 78 27 03 Fax +39 049 8211462 E-mail: [email protected] E-mail: [email protected] Dr. Gian Luca De Salvo Dr. Meriel Jenney International Data Centre Children Hospital for Wales Clinical trials and Biostatistics Unit Cardiff and Vale NHS Trust “Istituto Oncologico Veneto” Heath Park Via Gattamelata 64 - 35128 Padova, Italy Cardiff CF 14 4XW Tel +39 049 8215704 Tel +44 29 2074 2107 Fax +39 049 8215706 E-mail: [email protected] E-mail: [email protected] Dr. Hans Merks Department of Pediatric Oncology Emma Children’s Hospital – Academic Medical Center – University of Amsterdam Floor F8 – Room 245 Meibergdreef 9 Tel +31 20 5663050 Fax +31 20 6912231 E-mail: [email protected] 4 EpSSG NRSTS 2005 protocol Version 1.1 EpSSG NRSTS 2005 TRIAL MANAGEMENT COMMITTEE Dr. Andrea Ferrari (Coordinating Investigator) Dr. Bernadette Brennan Pediatric Oncology Unit, Royal Manchester Children’s Hospital Istituto Nazionale Tumori, Oxford Road, Manchester, M13 9 WL Via G. Venezian 1, 20133 Milano, Italy Tel +44 161 276 18443 Tel +39 02 23902588 Fax +44 161 276 18410 Fax +39 02 23902648 E-mail: [email protected] E-mail: [email protected] Dr. Gian Luca De Salvo Dr Anna Kelsey International Data Centre Department of Diagnostic Paediatric Clinical trials and Biostatistics Unit Histopathology “Istituto Oncologico Veneto” Royal Manchester Childrens Hospital Via Gattamelata 64 - 35128 Padova, Italy 4th Floor, Oxford Road, Manchester M13 9WL Tel +39 049 8215704 Telephone. 0161 701 2247-2240 Fax +39 049 8215706 Fax. 0161 701 2249 E-mail: [email protected] [email protected] Dr. Gianni Bisogno Dr. Daniel Orbach Haematology/Oncology Division Department of paediatric Institut Curie Department of Paediatric, 26 rue d’Ulm - 75995 Paris, France Via Giustiniani, 3 - 35128 Padova, Italy Tel +33 (0)1 44 32 45 51 Tel +39 049 8211481 Fax +33 (0)1 53 10 40 05 Fax +39 049 8211462 E-mail: [email protected] E-mail: [email protected] Dr. Michela Casanova Dr. Max Van Noesel Pediatric Oncology Unit, Erasmus MC/Sophia Children's Hospital Istituto Nazionale Tumori, Milano Dept. of Pediatric Oncology-Hematology Via G. Venezian 1, 20133 Milano, Italy Dr. Molewaterplein 60 Tel +39 02 23902588 3015 GJ Rotterdam, The Netherlands Fax +39 02 23902648 Tel +31-10-463 2073/6691 E-mail: [email protected] Fax +31-10-463 6801 E-mail: [email protected] Dr.
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