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STBSG – Current & recently closed trials

STBSG – Current & recently closed trials. CTOS 2005. PROTOCOL 62024: Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) randomized controlled trial of adjuvant imatinib mesylate (Glivec) versus no further therapy after complete surgery.

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STBSG – Current & recently closed trials

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  1. STBSG – Current & recently closed trials CTOS 2005

  2. PROTOCOL 62024: Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) randomized controlled trial of 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 • Stratification: • Risk category • Tumour site • Resection level • Main endpoint: • Overall survival • Secondary endpoints: • Relapse-free survival • Relapse-free interval • toxicity

  3. PROTOCOL 62024: Accrual

  4. PROTOCOL 62024: accrual according to stratification factors

  5. 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 • Eligibility: • Advanced/metastatic synovial sarcoma expressing HER1 Ag • Frozen tissue available for genetic confirmation of the diagnosis and molecular analysis • One previous line of chemotherapy containing doxorubicin and/or ifosfamide

  6. Study 62022Efficacy evaluation * 4 Patients with stable disease at week 12

  7. 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 disease • WHO PS < 2 • Stratification: • Age (<50 vs ≥50) • PS (0 vs 1) • Liver mets (0 vs +) • Histological grade (2 vs 3)

  8. 62012Interim analysis and stopping rule • Stopping rule for toxicity • Stop if febrile neutropenia in 30% of the cycles • Documented cycles (Dox-Ifos): 114 • Cycles with febrile neutropenia: 25 (22%) • Interim analysis • 1st interim analysis after 52 progressions / deaths • Aim: to detect a doubling in 6-months PFS rate • 44 events have been recorded so far • Interim analysis foreseen in November

  9. 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 PrimitiveNeuroectodermal Tumour (PNET) Study Coordinator: I. Judson, London • VIDE: • Vincristine • Ifosfamide • Doxorubicin • Etoposide • Eligibility: • Ewing/PNET • < 50 years • No previous chemo Local therapy • VAI: • Vincristine • Actinomycin • Ifosfamide • Stratification: • Age • Local treatment • VAC: • Vincristine • Actinomycin D • Cyclophosphamide • Bu-mel: • Busulfan • Melphalan

  10. PROTOCOL 62981:Accrual graph for Rand. R1

  11. PROTOCOL 62981:Accrual graph for rand.R2loc

  12. PROTOCOL 62981:Accrual graph for rand.R2pulm

  13. 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

  14. Study 62027 Phase II study of Glivec (Imatinib) in locally advanced and/or metastatic soft tissue sarcomas expressing the t(17;22)(q22;q13) translocation resulting in a COL1A1/PDGF- fusion protein i.e DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF) Treatment scheme: Imatinib 400 mg bid least 14 weeks until progression or unacceptable toxicity Study Coordinator: Professor Allan van Oosterom, Leuven, Belgium

  15. EORTC 62961-ESHO RHT-95 study of neoadjuvant chemotherapy +/- regional hyperthermia REGISTRATION EVALUATION RESPONSE EIA 115+RHT 101 EIA 124+RHT 121 EIA 120+RHT 112 EIA 112+RHT 93 Arm A: Arm B: 13th week EIA 124 EIA 118 EIA 109 EIA 106 RADIOTHERAPY RESECTION SURRGICAL EIA 67+RHT 53 EIA 65+RHT 50 EIA 60+RHT 44 EIA 53+RHT 36 ResponderCR, PRorStable Disease Arm A: Arm B: FU EIA 58 EIA 54 EIA 47 EIA 45

  16. Trial 62043: Phase II trial of angiogenesis inhibitor GW786034 Study Coordinator :Pr Jaap Verweij (Rotterdam, NL) • Oral GW786034 – inhibitor of VEGFR-1, VEGFR-2, VEGFR-3 • 800 mg PO once daily • Primary end-point progression-free survival at 12 weeks • Secondary end-points: overall PFS, response, overall survival, toxicity

  17. Scope for collaboration • Dox v Dox/ifos study if IDMC report due end November recommends study continues • Future trials in rare subtypes • Urgent need to solve barriers to EORTC / SARC intergroup collaboration We’re working on it!

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