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Brief Title: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
Official Title: 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 Received Three Cycles of Platinum Doublet Chemotherapy
Study ID: NCT03498521
Brief Summary: This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Blacktown Hospital, Blacktown, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Peter MacCallum Cancer Center, North Melbourne, Victoria, Australia
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie, Graz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei, Wien, , Austria
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
MHAT Nadezhda, Sofia, , Bulgaria
MBAL Serdika EOOD, Sofia, , Bulgaria
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, , Chile
James Lind Centro de Investigación Del Cáncer, Temuco, , Chile
Clinica del Country, Bogota, , Colombia
Inst. Nacional de Cancerologia; Clinica de Seno, Bogota, , Colombia
Oncomedica S.A., Monteria, , Colombia
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Praha 2, , Czechia
Aarhus Universitetshospital; Afdeling for Eksperimentel Klinisk Onkologi, Aarhus N, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy, Tallinn, , Estonia
Helsinki University Central Hospital; Dept of Oncology, Helsinki, , Finland
Tampere University Hospital; Dept of Oncology, Tampere, , Finland
Ico - Paul Papin, Angers, , France
CHRU Besançon, Besançon, , France
Institut Bergonie; Oncologie, Bordeaux, , France
CRLCC-Francois Baclesse; Oncologie Médicale, Caen, , France
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne, Clermont-ferrand, , France
Centre Leon Berard, Lyon, , France
Institut Paoli-Calmettes; Oncologie Medicale 1, Marseille Cedex 09, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie; Oncologie Medicale, Paris, , France
CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon), , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
CHU Strasbourg Hôpital Hautepierre, Strasbourg, , France
Hopital Foch; Oncologie, Suresnes, , France
Institut Gustave Roussy, Villejuif, , France
Universitätsklinikum Augsburg; II. Med. Klinik, Augsburg, , Germany
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo., Berlin, , Germany
Onkologisches Zentrum - Onkologie Dachau, Dachau, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Universitätsklinikum Düsseldorf; Klinik für Hämatologie, Onkologie und Klinische Immunologie, Düsseldorf, , Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie, Essen, , Germany
Universitätsklinikum Frankfurt, UCT; Universitäres Centrum für Tumorerkrankungen, Frankfurt, , Germany
Universitätsklinikum Heidelberg;Innere Medizin V, Hämatologie/Onkologie, Heidelberg, , Germany
SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm., Heilbronn, , Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II; Hämatologie und Internistische Onkologie, Jena, , Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik, Mainz, , Germany
Klinikum Mannheim III. Medizinische Klinik, Mannheim, , Germany
Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU, München, , Germany
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie, Münster, , Germany
RED-Oncology GmbH; Dres.Gerdt Hübner/Clemens Engels (Oldenburg)/Yael Bonnin-Gruber (Eutin), Oldenburg / Holstein, , Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens, , Greece
IASO General Hospital of Athens, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
Uni Hospital of Ioannina; Oncology Dept., Ioannina, , Greece
Theagenio Anticancer Hospital; 3Rd Oncology Clinic, Thessaloniki, , Greece
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest, , Hungary
Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály, Budapest, , Hungary
Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ, Kecskemét, , Hungary
St Vincent'S Uni Hospital; Medical Oncology, Dublin, , Ireland
Waterford Regional Hospital; Department Of Medical Oncology, Waterford, , Ireland
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Chaim Sheba medical center, Oncology division, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv, , Israel
U. O. Oncologia Medica, Ospedale Santa Chiara, Pisa, Basilicata, Italy
Policlinico Univ. - A.O. Mater Domini; U.O. Di Oncoematologia, Catanzaro, Calabria, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Arcispedale Santa Maria Nuova; Oncologia, Reggio Emilia, Emilia-Romagna, Italy
Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck, Milano, Lombardia, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima, Padova, Veneto, Italy
Aichi Cancer Center, Aichi, , Japan
National Cancer Center Hospital East, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System; Oncology, Seoul, , Korea, Republic of
Riga East Clinical University Hospital Latvian Oncology Centre, Riga, , Latvia
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
AVIX Investigación Clínica S.C, Monterrey, Nuevo LEON, Mexico
Erasmus MC, Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Ziekenhuis VieCuri Medisch Centrum, Venlo, , Netherlands
Sørlandet Sykehus Kristiansand, Kristiansand, , Norway
Akershus universitetssykehus HF, Lørenskog, , Norway
Oslo universitetssykehus HF, Ullevål, Kreftsenteret, Oslo, , Norway
Oncosalud Sac; Oncología, Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Kraków, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz, Warszawa, , Poland
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala, Cluj Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie, Craiova, , Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie, Iasi, , Romania
Oncocenter Timisoara, Timi?oara, , Romania
Hospital Sant Joan Despi- Moises Broggi; Servicio de Oncologia, Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología, Vigo, Pontevedra, Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe; Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Universitaetsspital Basel; Onkologie, Basel, , Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Ankara University Medical Faculty; Medikal Onkoloji, Ankara, , Turkey
Ankara Oncology Hospital; Oncology, Ankara, , Turkey
Akdeniz University Medical Faculty; Medical Oncology Department, Antalya, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani, Istanbul, , Turkey
?zmir Medical Point; Oncology, Kar?iyaka, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Royal United Hospital; Oncology Department, Bath, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Western General Hospital; Edinburgh Cancer Center, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Hammersmith Hospital; Garry Weston Centre, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Torbay Hospital; Oncology Department, Torquay, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR