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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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EORTC STBSG

Ongoing clinical trials

Venice, November 4th


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


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


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 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)


    Study 62012: accrual on 30/10

    204 patients


    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


    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


    PROTOCOL 62024: Accrual by Group


    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).

    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


    62027 Accrual


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

    EORTC study 62043


    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

    EORTC study 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

    • 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

    EORTC study 62061

    Study Coordinator :Dr. Hans Gelderblom


    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


    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

    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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