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EORTC STBSG

EORTC STBSG. Ongoing clinical trials Venice, November 4th. A RANDOMIZED STUDY COMPARING NEOADJUVANT CHEMOTHERAPY ETOPOSIDE + IFOSFAMIDE + ADRIAMYCIN (EIA) COMBINED WITH REGIONAL HYPERTHERMIA (RHT) VS. NEOADJUVANT CHEMOTHERAPY ALONE

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EORTC STBSG

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  1. EORTC STBSG Ongoing clinical trials Venice, November 4th

  2. A RANDOMIZEDSTUDY COMPARINGNEOADJUVANT CHEMOTHERAPY ETOPOSIDE + IFOSFAMIDE + ADRIAMYCIN (EIA) COMBINED WITH REGIONAL HYPERTHERMIA (RHT) VS. NEOADJUVANT CHEMOTHERAPY ALONE IN THE TREATMENT OF HIGH-RISK SOFT TISSUE SARCOMAS IN ADULTS AN INTERGROUP STUDY WITH THE EUROPEAN SOCIETY FOR HYPERTHERMIC ONCOLOGY

  3. PROTOCOL 62981: Randomized Phase III study to evaluate the role of high dose chemotherapy intensification in the treatment of intermediate prognosis Ewing’s sarcoma and Primitive Neuroectodermal Tumour (PNET) Study Coordinator: I. Judson, London • VIDE: • Vincristine • Ifosfamide • Doxorubicin • Etoposide • Eligibility: • Ewing/PNET • < 50 years • No previous chemo • VAI: • Vincristine • Actinomycin • Ifosfamide • Stratification: • Age • Local trt of primary • VAC: • Vincristine • Actinomycin D • Cyclophosphamide • Bu-mel: • Busulfan • Melphalan

  4. PROTOCOL 62991-22998: Phase II study of moderate dose radiotherapy for inoperable aggressive fibromatosis Study coordinator: Ronald KEUS, Arnhem • Eligibility: • Histologically confirmed aggressive fibromatosis • Measurable disease (RECIST) • No current endocrine or chemotherapy, no prior or concurrent limb perf with TNF • >15 years

  5. PROTOCOL 62991-22998: ACCRUAL GRAPH

  6. PROTOCOL 62012: Randomized trial of single agent doxorubicin versus doxorubicin plus ifosfamide Study Coordinator: I. Judson, London • Eligibility: • High grade STS (2-3) • Age 16-60 • No previous chemo for adv/met dis • WHO PS < 2 • Stratification: • Age (<50 vs ≥50) • PS (0 vs 1) • Liver mets (0 vs +) • Histological grade (2 vs 3)

  7. Study 62012: accrual on 30/10 204 patients

  8. PROTOCOL 62022: Phase II study of Iressa (ZD1839) in locally advanced and/or metastatic synovial sarcoma Study Coordinator: J-Y Blay, Lyon ZD1839 500 mg/day orally once a day for at least 52 weeks • Eligibility: • Advanced/metastatic synovial sarcoma expressing HER1 Ag (DAKO or another mAb) • Frozen tissue available for genetic confirmation of the diagnosis and molecular anal. • One previous line of chemotherapy containing doxorubicin and/or ifosfamide

  9. PROTOCOL 62024: Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery Collaborating Groups: ISG, FSG, EORTC STBSG, GEIS, AGITG Study Coordinators: P. CASALI, Milan (ISG) and J-Y BLAY, Lyon (EORTC STBSG) • Eligibility: • GIST with positive immunostaining for KIT • Risk of relapse documented on surgical specimen • No evidence of residual macroscopic disease after surg • No distant metastases • WHO PS 0-2, age >17 • No prior radiation therapy /chemotherapy After complete surgery • Stratification: • Risk category • Tumour site • Resection level • Main endpoint: • Overall survival • Secondary endpoints: • Relapse-free survival • Relapse-free interval • toxicity

  10. PROTOCOL 62024: Accrual by Group

  11. PROTOCOL 62024: Stratification factors

  12. PROTOCOL 62027: Phase II study of Glivec (Imatinib) in locally advanced and/or metastatic soft tissue sarcoma expressing the t(17;22)(q22;q13) translocation resulting in a COL1A1/PDGF-beta fusion protein i.e DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF). Study Coordinator: A.T. Van Oosterom, Leuven GLIVEC 400 mg bid for at least 14 weeks • Eligibility: • Histologically proven locally advanced or metastatic DFSP or GCF • Progressive disease documented in the last 3 months • Disease not amenable to surgery, radiation or combined modality treatment with curative intent • Frozen tumor or paraffin embedded tissue available for immunohistochemical, molecular analysis and central path. review • No prior chemotherapy or no more than 1 line combination chemo with Ifosfamide and Doxorubicin or 2 lines of single agent therapy or relapsing within 6 months after end of adjuvant chemo. • WHO PS 0-2, age 18 years or more

  13. 62027 Accrual

  14. Phase II study of GW786034 in patients with relapsed or refractory soft tissue sarcoma EORTC study 62043

  15. Accrual graph (cut-off 11 Oct ’06)

  16. Phase II study of E7389 administered as an IV infusion day 1 and 8 every 3 weeks in pretreated patients with advanced and/or metastatic soft tissue sarcoma EORTC study 62052

  17. Trial 62052 Study Coordinator :Dr. Patrick Schoeffski (Leuven, Belgium) Date of PRC protocol approval:July 17, 2006 Version and date of last amendment: first amendment (non-substantial) protocol version 1.1, August 8, 2006 Treatment scheme : Intravenous bolus of E7389 (1.4 mg/m²) on days 1 and 8 every 21 days

  18. Sample size • The trial will be independently conducted in 4 groups of patients (strata) : • Leiomyosarcoma • Liposarcoma • Synovial sarcoma • Other types of eligible STS • STEP 1: 17 eligible patients per stratum • STEP 2: • if > 3 successes in step 1 : continue up to 37 eligible patients per stratum

  19. Randomized Phase II study of brostacillin (PNU-166196A) versus doxorubicin as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma EORTC study 62061 Study Coordinator :Dr. Hans Gelderblom

  20. Trial 62061 Date of PRC protocol approval :June 29, 2006 Treatment scheme : max 6 cycles treatment ARM A : Brostallicin 10 min. IV infusion (10 mg/m²) on day 1 of a q3w cycle (12.5 mg/m² from second cycle in case of good tolerance) ARM B :Doxorubicin IV bolus (75 mg/m²) on day 1 of a q3w cycle Sample Size : 72 (brostacillin) + 36 (doxorubicin)

  21. Eligibility Main eligibility criteria : • Histological or cytological confirmed high or intermediate grade malignant soft tissue sarcoma • Objective documentation of disease progression within the last 6 months. Relapsed or refractory disease incurable by surgery or radiotherapy. Presence of measurable disease (RECIST). • No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant therapy is allowed. • At least 60 years of age, or patients at least 18 years of age non suitable for intensive chemotherapy combination treatments • WHO performance status 0 or 1 • Adequate bone marrow, hepatic and renal function

  22. End-Points Primary: • 6 months progression-free survival (assessed at 26 weeks) Secondary: • Overall progression-free survival • Overall survival • Objective tumor response (RECIST) • Duration of response

  23. Participating countries UK (6) The Netherlands (5) CA & EC approval Germany (7) Belgium (3) CA & EC approval Poland (1) France (3) Slovakia (1) EC approval 26 sites in 7 countries

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