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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

EORTC STBSG

Ongoing clinical trials

Venice, November 4th


Eortc stbsg

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


Eortc stbsg

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


Eortc stbsg

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

    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)


    Eortc stbsg

    Study 62012: accrual on 30/10

    204 patients


    Eortc stbsg

    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


    Eortc stbsg

    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: Accrual by Group


    Protocol 62024 stratification factors

    PROTOCOL 62024: Stratification factors


    Eortc stbsg

    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

    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)


    Eortc study 62052

    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


    Eortc study 62061

    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

    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

    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

    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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