Studienübersicht Onkologie Dezember 2012

Transkript

1 Lunge NSCLC Stage III A Phase III 16/00 Preoperative chemoradiotherapy versus chemotherapy alone in NSCLC patients with mediastinal lymph node metastases (stage III A ; N2): 1 NSCLC Adeno Stage IV Phase II 19/09 BIO-PRO Bevacicumab, pemetrexed and cisplatin, or erlotinib and bevacizumab, non-squamous NSCLC stratified by EGFR-mutation status. phase II including biopsy at progression. 1 NSCLC Stage IV 2nd line Phase III JVBA (Eli Lilly) A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy ELI Lilly 1 ALK+ NSCLC Phase III Pfizer NSCLC Profile1014 Randomisierte, offene Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Crizotinib im Vergleich zu Pemetrexed/Cisplatin oder Pemetrexed/Carboplatin bei nicht vorbehandelten Patienten mit Nicht-Plattenepithelkarzinom der Lunge mit einer Translokation oder Inversion im Genlokus der anaplastischen Lymphomkinase (ALK) Pfizer 1 EGFR mut+ NSCLC Phase II ETOP BELIEF NSCLC 2nd line squamous Phase III ETOP EMPHASIS BELIEF: Eine Phase-II-Studie mit Erlotinib und Bevacizumab bei Patientinnen und Patienten mit einem fortgeschrittenen nichtkleinzelligen Lungenkarzinom und aktivierenden EGFR-Mutationen A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell nonsmall lung cancer who failed fist line platium based doubelt chemotherapy stratified by VeriStrat Goos vs VeriStrat Poor ETOP 1 ETOP 1 1.PI: PD Dr. O. Gautschi, 2 PI: Prof. Dr. S. Aebi, 3 PI: Dr. R. Winterhalder, 4.PI: Dr. T. Zander

2 MAMMA HER2-positive primary breast cancer adjuvant Phase III Roche APHINITY Randomisierter, multizentrischer, doppelblinder, Placebo-kontrollierter Vergleich von Chemotherapie plus Trastuzumab plus Placebo versus Chemotherapie plus Trastuzumab plus Pertuzumab als adjuvante Therapie bei Patientinnen mit operablem, HER2-positivem, primärem Brustkrebs F. Hoffmann-La Roche Ltd 2 early stage breast cancer Phase III IBCSG MA.32 A PHASE III RANDOMIZED TRIAL OF METFORMIN VERSUS PLACEBO ON RECURRENCE AND SURVIVAL IN EARLY STAGE BREAST CANCER IBCSG / 2 1.PI: PD Dr. O. Gautschi, 2 PI: Prof. Dr. S. Aebi, 3 PI: Dr. R. Winterhalder, 4.PI: Dr. T. Zander

3 GASTROINTESTINAL Colon elderly Metastatic, first line Phase II (noch geschlossen) 41/10 Cetuximab monotherapy and cetuximab plus capecitabine as first-line treatment in elderly patients with KRAS- and BRAF wild-type metastatic colorectal cancer. A multicenter phase II trial 3 Colon Metastatic, first line Phase II Roche MAVERICC Rektum Chirurgie Phase III 40/04 A randomized phase II study of bevacizumab / m FOLFOX6 vs bevacizumab / FOLFIRI with biomarker stratification in patients with previously untreted metastatic colorectal cancer Clinical function after total mesorectal excision and rectal replacement. A prospective randomized trial comparing side-to-end anastomosis, colon-j-pouch and straight coloanal anastomosis. Roche 3 Rektum Resektabel, neoadjuvant, K-ras mutiert Phase I/II a 41/08 Neoadjuvant radiotherapy combined with Capecitabine and Sorafenib, K-ras mutated rectal cancer. phase I/IIa. 3 Oesophagus Operabel, neoadjuvant Phase III 75/08 Neoadjuvant radiochemotherapy with and without cetuximab. phase III. 3 Metastatic gastroesophageal cancer (HER2-negative),first line Phase III Roche YO28322 Eine randomisierte, multizentrische, doppelblinde, placebokontrollierte Phase-III-Studie zur Untersuchung der Wirksamkeit und Sicherheit von Onartuzumab (MetMAb) in Kombination mit 5-FluorouracilL, Folinsäure und Oxaliplatin (mfolfox6) bei Patienten mit metastasiertem, HER2-negativem, MET-positiviem gastroösophagealem Karzinom Roche 3 Colon Metastatic Phase IV COMPANION A prospective non-interventional evaluation of epidermal growth factor inhibitor skin toxicity management and adherence to epidermal growth factor inhibitor treatment in patients with metastatic colorectal cancer Amgen 3 1.PI: PD Dr. O. Gautschi, 2 PI: Prof. Dr. S. Aebi, 3 PI: Dr. R. Winterhalder, 4.PI: Dr. T. Zander

4 UROGENITAL Prostata Registerstudie SEQOND QoL in 2 nd line therapy Sanofi 3 Prostata Phase III 09/10 Dose intensified salvage radiotherapy in biochemically relapsed prostate cancer without macroscopic disease. A randomized phase III trial 3 Prostata Phase III 08/11 Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and nonprogressive disease after first line chemotherapy with docetaxel: a multicenter randomized double-blind placebo controlled phase III trial 3 3 PI: Dr. R. Winterhalder Lymphomas Follikuläres Lymphom Phase II 35/10 Offene, multizentrische, randomisierte Phase-II-Studie mit Rituximab plus Lenalidomid beziehungsweise Rituximab als Monotherapie bei behandlungsnaiven Patienten mit behandlungsbedürftigem follikulärem Lymphom 4 Multiple Myeloma first line Phase III EMN02 - Hovon - 95 A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma 4 Multiple Myeloma relapsed or refractory Phase II BRd An open, multicentric phase II trial to evaluate the efficacy and safety of Bendamustine, Lenalidomide (Revlimid ) and Dexamethasone (BRd) as 2nd-line therapy for patients with relapsed or refractory multiple myeloma Kantonsspital St. Gallen 4 Diffuse Large B-cell Lymphoma noch geschlossen REMoDL-B A Randomized Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma with Bortezomib 4 4.PI: Dr. T. Zander

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6 DIVERSE Indikationen Pflegestudie SAEDA III SAEDA III Telefon-Follow-up bezüglich neuen Symptomen bei Therapie mit Fluoropyrimidin per oral Kantonsspital Graubünden IIT Lunge Grundlagenforschung ALK Nachweis von Mutationen im Blut von Patienten mit Lungentumoren Med Onkologie LUKS 1 Lunge Translationelle Forschung EAP EGFR Analyse im Rahmen des Gefitinib-Expanded Access Programm (EAP) AstraZeneca 1

7 Follow Up DCIS Phase III IBIS II Tam vs. Ana in postmenopausal women with DCIS Prevention Phase III IBIS II Study (IBIS) of anastrozole vs. placebo in postmenopausal women at increased risk of breast cancer Retrospective and Prospective Observational Study Retrospektiv Amgen NHL reviewing Supportive Care Management of NHL Patients treated with CHOP-14 or 21 (with or without Rituximab). Amgen Retrospective and Prospective Observational Study Retrospektiv Amgen solid tumors A Prospective Observational Study reviewing neutropenia and anemia risk management in subjects with Solid Tumors receiving Myelotoxic Chemotherapy Amgen Porstata Phase II 08/08 prostate cancer Phase II 08/07 Everolimus first-line therapy in non-rapidly progressive castration resistant prostate cancer (CRPC) Docetaxel and cetuximab in patients with docetaxelresistant hormone-refractory prostate cancer (HRPC) rectal cancer metastatic Phase II 41/07 Neoadjuvant radiotherapy and capecitabine with or without panitumumab in patients with advanced, K-ras unmutated rectal cancer metastatic ER/PR positive, PD after AI Phase II 21/08 Fulvestrant with or without AZD6244 MEK-inhibitor, after AI. randomized phase II, placebo-controlled

8 Follow Up Prostata Phase III 09/10 Dose intensified salvage radiotherapy in biochemically relapsed prostate cancer without macroscopic disease A randomized phase III trail Colon Metastatic, first line (maintenance) Phase III 41/06 metastatic Her2 negative 1 st line Phase III 24/09 metastatic Phase III Roche EMILIA Bevacizumab maintenance versus no maintenance after bevacizumab-containing first line chemotherapy. phase III Bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine. phase III. A randomized, multicenter, phase iii open-label study of the efficacy and safety of trastuzumab-mcc-dm1 vs. Capecitabine + lapatinib in patients with her2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy 3 F. Hoffmann-La Roche Ltd 3