EORTC STBSG

EORTC STBSG : EORTC STBSG Ongoing clinical trials Venice, November 4th


Slide2 : A RANDOMIZED STUDY COMPARING NEOADJUVANT 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


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) : 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) Stratification: Age Local trt of primary VIDE: Vincristine Ifosfamide Doxorubicin Etoposide VAI: Vincristine Actinomycin Ifosfamide VAC: Vincristine Actinomycin D Cyclophosphamide Bu-mel: Busulfan Melphalan Study Coordinator: I. Judson, London Eligibility: Ewing/PNET < 50 years No previous chemo


PROTOCOL 62991-22998: Phase II study of moderate dose radiotherapy for inoperable aggressive fibromatosis : 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


PROTOCOL 62991-22998: ACCRUAL GRAPH : PROTOCOL 62991-22998: ACCRUAL GRAPH


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


Slide11 : Study 62012: accrual on 30/10 204 patients


PROTOCOL 62022: Phase II study of Iressa (ZD1839) in locally advanced and/or metastatic synovial sarcoma : PROTOCOL 62022: Phase II study of Iressa (ZD1839) in locally advanced and/or metastatic synovial sarcoma ZD1839 500 mg/day orally once a day for at least 52 weeks Study Coordinator: J-Y Blay, Lyon 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


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 : 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 Stratification: Risk category Tumour site Resection level 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 Main endpoint: Overall survival Secondary endpoints: Relapse-free survival Relapse-free interval toxicity Collaborating Groups: ISG, FSG, EORTC STBSG, GEIS, AGITG


PROTOCOL 62024: Accrual by Group : PROTOCOL 62024: Accrual by Group


PROTOCOL 62024: Stratification factors : PROTOCOL 62024: Stratification factors


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). : 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). GLIVEC 400 mg bid for at least 14 weeks Study Coordinator: A.T. Van Oosterom, Leuven 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


62027 Accrual : 62027 Accrual


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


Accrual graph (cut-off 11 Oct ’06) : Accrual graph (cut-off 11 Oct ’06)


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 : 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


Trial 62052 : 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


Sample size : 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


Randomized Phase II study of brostacillin (PNU-166196A) versus doxorubicin as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma : 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


Trial 62061 : 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)


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 Eligibility


End-Points : 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


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