EORTC 10085 PRO EORTC 10085 prospective part, Clinical and biological characterization of Male Breast Cancer: an international EORTC, BIG and NABCG inter study 30 30-Jun-2016 estelle.cassoly@sakk.ch IBCSG 48-14 POSITIVE A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE) 500 3 30-Jun-2018 Breast IBCSG 50-14 OLYMPIA A randomised, double-blind, parallel, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with high risk germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy 1320 0 31-Mar-2019 ibcsg50_olympia@fstrf.org SAKK 23/13 Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer. A Multicenter Randomized Phase III Trial. 142 76 31-Dec-2016 estelle.cassoly@sakk.ch 09.05.2016 1/8
SAKK 25/14 Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial 77 18 15-Aug-2018 daniela.baertschi@sakk.ch SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial 1380 268 (131 Breast) 16-Jan-2019 andrea.fuhrer@sakk.ch Gastrointestinal PROSPECT SAKK 41/14 A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resec-tion with total mesorectal excision. Physical activity program in patients with metastatic colorectal cancer who receive palliative firstline chemotherapy. A multicenter open label randomized controlled phase III trial 1060 7 (in CH) 30-Jun-2017 mario.baresic@sakk.ch 524 1 30-Sep-2021 catherine.berset@sakk.ch 09.05.2016 2/8
Gynaecological INOVATYON Phase III international, randomized study of trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum Mito/Mango 16b A multicenter phase III randomized study with second line chemotherapy plus or minus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab/chemotherapy first line 588 23 (in CH) 30-Jun-2017 400 14 (in CH) 01-Jan-2017 moritz.jacobshagen@sakk.ch heidi.baumgartner@sakk.ch APL 2006 CML-V Randomized phase III trial assessing the role of arsenic trioxide and/or ATRA during consolidation course in newly diagnosed acute promyelocytic leukemia (APL) Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy 800 65 (in CH) 15-May-2016 vincent.tchang@sakk.ch 628 27 (in CH) 30-Sep-2016 moritz.jacobshagen@sakk.ch 09.05.2016 3/8
Leukemias EBMT HCT vs CT HOVON 103 - TOS Compare conventinal chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy. A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years. 231 10 (in CH) 30-Jun-2016 joerg.brechbuehl@sakk.ch 200 29 (in CH) 15. Aug 16 andrea.fuhrer@sakk.ch HOVON 132 Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5) 860 81 (in CH) 30. Apr 17 andrea.fuhrer@sakk.ch 09.05.2016 4/8
ETOP PEARLS A randomized, phase 3 trial with anti-pd-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) ETOP SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC 1380 0 (in CH) 30-Jun-2023 1000 59 (in CH) 30-Mar-2018 PEARLS@etop-eu.org SPLENDOUR@etop-eu.org Lung Lung ART EORTC LungArt: Phase III study comparing post-operative conformal radiotherapy to no postoperative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement 700 2 (in CH) 31-Dec-2018 oussama.karroum@eortc.be SAKK 15/12 Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial 42 15 31-Mar-2018 andrea.fuhrer@sakk.ch 09.05.2016 5/8
HD 17 Therapieoptimierungsstudie in der Primärtherapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels FDG- PET 1100 63 01-Dec-2016 katrin.eckhardt@sakk.ch IELSG-37 A randomized, open-label, multicentre, two-arm phase III comparative study assessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) 540 10 31-Dec-2016 simona.berardi@sakk.ch SAKK 35/14 Rituximab with or without ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial. 190 5 31-Dec-2017 vincent.bize@sakk.ch Lymphomas SAKK 36/13 Combination of ibrutinib and Bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma. A multicenter Phase I/II trial 73 4 31-Mar-2018 katrin.eckhardt@sakk.ch 09.05.2016 6/8
SAKK 39/10 Nelfinavir and lenalidomide/dexamethasone in patients with progressive multiple myeloma that have failed lenalidomide-containing therapy. A single arm phase I/II trial. 33 29 30-Jun-2016 piera.gargiulo@sakk.ch SAKK 39/13 Nelfinavir as Bortezomibsensitizing drug in patients with proteasome inhibitornonresponsive myeloma. A multicenter phase II trial. 34 32 31-Aug-2016 catherine.berset@sakk.ch T-Cell Project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der T-Zell Linie zu gewinnen. Nachträgliche Erfassung im PATRAS am 06.09.2013, Freigabe ca. 2008/2009. 35 (in CH) 31-Dec-2016 simona.berardi@sakk.ch New Drugs SAKK 66/12 A Phase I, open-label, multicenter, dose escalation study of oral CGM097, a p53/hdm2- interaction inhibitor, in adult patients with se-lected advanced solid tumors characterized by wildtype TP53 6 (in CH) 30-Jun-2016 simona.berardi@sakk.ch SAKK 66/13 INC280 Combination with BKM120 for glioblastoma patients, Phase I/II trial 58 2 (in CH) 30-May-2016 simona.berardi@sakk.ch 09.05.2016 7/8
SAKK 01/10 SAKK 06/14 Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy 115 60 15-Jun-2017 39 4 30-Jun-2017 ruth.weiss@sakk.ch milica.enoiu@sakk.ch Urogenital SAKK 63/12 SAKK 96/12 Prospective cohort study with collection of clinical data and serum of patients with prostate disease Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial 1930 289 15-Oct-2019 1380 268 (137 Uro) 16-Jan-2019 vincent.bize@sakk.ch andrea.fuhrer@sakk.ch STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy A multiarm multi-stage randomised controlled trial 58 (in CH) 31-Dec-2016 estelle.cassoly@sakk.ch changed since last issue 09.05.2016 8/8