1 / 17

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.

zeno
Download Presentation

STBSG – Current & recently closed trials

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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!

More Related