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Focus-Empfohlener-Arzt 2022

2022 Plakette Empfehlungsarzt2022 Onkologe Landkreis Donau RiesZum sechsten Mal in Folge wurde Prof. (SHB) Dr. med. Dirk Hempel im Mai 2022 mit seinen Tagesklinik in Donauwörth erneut von FOCUS-GESUNDHEIT ausgezeichnet.

CUPISCO

CUPISCO

A phase II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemotherapy in patients with cancer of unknown primary site who have recieved three cycles of platinum doublet chemotherapy

 

Specifications

  • Sponsor:     F. Hoffmann-La Roche LTD.

    EudraCT:    2017-003040-20

     

    Inclusion Criteria:

    • Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP
    • No prior lines of systemic therapy for the treatment of CUP
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy)
    • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
    • Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample </= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory
    • No brain metastasis (pretreated brain metastasis without residual disease or leptomeningeal disease is accepted)

     

    Exclusion Criteria:

    • Squamous cell CUP
    • Participants belonging to any of the following subsets of CUP with favorable prognoses: Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile
    • Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only)
    • Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma
    • Immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
    • History or known presence of leptomeningeal disease
    • Known human immunodeficiency virus (HIV) infection
    • Significant cardiovascular disease
    • Prior allogeneic stem cell or solid organ transplantation
    • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 24 months after the last dose of study treatment

Internisten • Hämatologen • Onkologen • Palliativmedizin • Onkologische Tagesklinik

Onkologische Zentren
Prof. (SHB) Dr. med. Dirk Hempel