Исследование Debio 1143 (Ксевинапант) в оценке с химиотерапией на основе платины и лучевой терапии с модулированием лечения стандартной фракционной терапией у участников с местнораспространенной плоскоклеточной карциномой головы и груди, при выраженной оценке лучевой терапии (TrilynX)

Название протокола
Клинические исследование Efficacia e sicurezza di FITpatch rispetto al trattamento standard con oppioidi nel dolore da cancro (FT-015-IN): Debio 1143, Цисплатин, Лучевая терапия с модуляцией интенсивности (IMRT), Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: EMD Serono Research & Development Institute, Inc.

Коллаборационист: GORTEC (Head and Neck Oncology and Radiotherapy Group)
Merck KGaA, Darmstadt, Germany

Источник EMD Serono
Краткое содержание

Основная цель исследования — по сравнению с более высокой эффективностью Debio 1143 плацебо при добавлении к химиолучевой терапии (ХЛТ) при прямо-пространственном плоскоклеточном раке голова и шея (LA-SCCHN).

Общий статус Рекрутинг
Дата начала 2020-08-07
Дата завершения 2027-04-30
Дата первичного завершения 2024-12-01
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Бессобытийное выживание (БЭС) до 5 лет
Вторичный результат
Мера Временное ограничение
Progression-Free Survival (PFS) Up to 5 years
Общая выживаемость (ОС) до 5 лет
Местно-региональный контроль (LRC) От рандомизации до самого раннего между событием ВБП (прогрессирование в месте первичной опухоли или локорегионарных лимфатических узлов) или EOS (до 5 лет)
Безопасность и переносимость, оцениваемые по частоте и тяжести нежелательных явлений (НЯ), серьезных нежелательных явлений (СНЯ), нежелательных явлений особого интереса (НПСИ), изменений лабораторных показателей, основных показателей жизнедеятельности, электрокардиограммы (ЭКГ) и степени воздействия От подписанного информированного согласия на EOS (в течение 6,8 лет)
Изменения общего состояния здоровья/качества жизни (GHS/QoL) и симптома утомляемости по сравнению с исходным уровнем До первой дозы исследуемого препарата (исходный уровень) и во время последнего последующего наблюдения (до 5 лет)
Изменения по сравнению с исходным уровнем в глотании и болевых симптомах До первой дозы исследуемого препарата (исходный уровень) и во время последнего последующего наблюдения (до 5 лет)
Регистрация 700
Состояние
  • Efficacia e sicurezza di FITpatch rispetto al trattamento standard con oppioidi nel dolore da cancro (FT-015-IN)
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Debio 1143

Описание: Debio 1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.

Этикетка Arm Group: Debio 1143

Другое имя: xevinapant

Тип вмешательства: Фармакокинетическое исследование пиротиниба и доцетаксела в сочетании с трастузумабом, пациентом с метастазами HER2 и бронхиальным раком

Название вмешательства: Цисплатин

Описание: Цисплатин выходит внутривенно обычно 3 недели (Q3W).

Тип вмешательства: Радиация

Название вмешательства: Лучевая терапия с модуляцией интенсивности (IMRT)

Описание: 70 Гр в 35 фракциях в течение 7 недель.

Тип вмешательства: Фармакокинетическое исследование пиротиниба и доцетаксела в сочетании с трастузумабом, пациентом с метастазами HER2 и бронхиальным раком

Название вмешательства: Плацебо

Описание: Достаточное количество плацебо вводили в виде поступлений для поступивших с 1 по 14 день, каждый 21-дневный цикл.

Этикетка Arm Group: Плацебо

Приемлемость

Критерии:

Критерии включения: - Статус эффективности восточной онкологической группы (ECOG PS) 0 или 1 - Гистологически подтвержденный диагноз при ранее не леченном местно-распространенном плоскоклеточном раке. Участник клеточной карциномы головы и опухоли (LA-SCCHN) (стадии III, IVa или IVb). согласно Американскому объединенному комитету по раку (AJCC))/Классификация раковых заболеваний опухоль: T = увеличение опухоли, N = поражение регионарных очагов воспаления, M = отдаленное поражение система стадирования метастазов (TNM), 8-е издание.) подходит для окончательного Химиолучевая терапия (ХЛТ), по случаю, в одном из следующих мест: ротоглотка, гипофаринкс и гортань - Для участников с раком ротоглотки (OPC) первичные опухоли должны быть человеческими. папилломавирус (ВПЧ)-отрицательный, как определено по экспрессии p16 при сборе иммуногистохимия - Поддающаяся оценке опухолевая нагрузка (измеряемые и/или неизмеряемые опухолевые компоненты), оцениваемая компьютерная томография (КТ-сканирование) или магнитно-резонансная томография (МРТ), основанная на Критерии оценки ответа при солидных опухолях (RECIST), версия 1.1 - Периферическая невропатия меньше или равна (10% в течение последних 4 недель до рандомизации (если только приемные меры для нутритивной поддержки), ИЛИ плазменный альбумин < 3,0 г/дл. За 2 недели до рандомизации не принято решение о переливании альбумина. - Известная аллергия на Debio 1143, цисплатин, карбоплатин, другие средства на основе платины или любые другие вещества. повышенное содержание - составление списка других характеристик, основанных на протоколе

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

Н/Д

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Medical Responsible Study Director Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Общий контакт

Фамилия: US Medical Information

Телефон: 888-275-7376

Расположение
Объект: Положение дел:
Banner MD Anderson Cancer Center | Gilbert, Arizona, 85234, United States Recruiting
University of Arizona Cancer Center | Tucson, Arizona, 85724, United States Recruiting
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States Not yet recruiting
Regents of the University of California | San Francisco, California, 94158, United States Recruiting
University of Colorado at Denver and Health Sciences Center | Aurora, Colorado, 80045, United States Recruiting
Yale Cancer Center | New Haven, Connecticut, 06519, United States Recruiting
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center | Washington, District of Columbia, 20007, United States Recruiting
Moffitt Cancer Center | Tampa, Florida, 33612, United States Active, not recruiting
ASCLEPES Research Centers | Weeki Wachee, Florida, 34607, United States Recruiting
Columbus Regional Research Institute | Columbus, Georgia, 31904, United States Recruiting
IACT Health, John B. Amos Cancer Center | Columbus, Georgia, 31904, United States Recruiting
Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana, 46804, United States Recruiting
Ashland-Bellefonte Cancer Center | Ashland, Kentucky, 41101, United States Suspended
Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus | Louisville, Kentucky, 40241, United States Recruiting
Massachusetts General Hospital | Boston, Massachusetts, 02114-2696, United States Active, not recruiting
Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center | Boston, Massachusetts, 02215, United States Active, not recruiting
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting
University South Hospital | Ann Arbor, Michigan, 48109-9001, United States Recruiting
Henry Ford Health System | Detroit, Michigan, 48202, United States Not yet recruiting
Karmanos Cancer institute | Detroit, Michigan, 48302, United States Recruiting
University of Missouri - Ellis Fischel Cancer Center | Columbia, Missouri, 65212, United States Recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting
Cox Medical Centre South | Springfield, Missouri, 65807, United States Active, not recruiting
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, 89169, United States Active, not recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health | New York, New York, 10016, United States Active, not recruiting
NYU Grossman School of Medicine | New York, New York, 10016, United States Recruiting
Wake Forest University School of Medicine | Winston-Salem, North Carolina, 27157, United States Recruiting
University of Cincinnati Medical Center | Cincinnati, Ohio, 45267, United States Recruiting
University Hospital Cleveland Medical Center | Cleveland, Ohio, 44106, United States Recruiting
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting
Ohio State University | Columbus, Ohio, 43210, United States Not yet recruiting
University of Oklahoma Health Sciences Center- Stephenson Cancer Center | Oklahoma City, Oklahoma, 73104, United States Active, not recruiting
Providence Portland Medical Center | Portland, Oregon, 97213, United States Recruiting
Gettysburg Cancer Center | Gettysburg, Pennsylvania, 17325, United States Recruiting
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States Recruiting
Medical University of South Carolina- Hollings Cancer Center | Charleston, South Carolina, 29425, United States Recruiting
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Active, not recruiting
MD Anderson | Houston, Texas, 77030, United States Recruiting
IHO Corporation/Utah Cancer Specialists | Salt Lake City, Utah, 84106, United States Recruiting
University of Virginia Medical Center | Charlottesville, Virginia, 22908, United States Active, not recruiting
Hospital Aleman | Buenos Aires, Argentina Recruiting
Instituto de Investigaciones Medicas Alfredo Lanari - IDIM | Buenos Aires, Argentina Active, not recruiting
Instituto Medico Especialazado Alexander Fleming | Buenos Aires, Argentina Recruiting
Clinica Universitaria Reina Fabiola | Cordoba, Argentina Recruiting
Instituto de Oncologia de Rosario | Santa Fe, Argentina Recruiting
Clinica Viedma | Viedma, Argentina Recruiting
Ashford Cancer Centre Research, Tennyson Centre | Adelaide, Australia Recruiting
St Vincents Hospital | Darlinghurst, Australia Recruiting
St Vincents Hospital Melbourne | Fitzroy, Australia Recruiting
Peter MacCallum Cancer Centre | Melbourne, Australia Recruiting
Wollongong Hospital | Wollongong, Australia Recruiting
Princess Alexandra Hospital, Cancer Trials Unit | Woolloongabba, Australia Recruiting
Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde | Graz, Austria Active, not recruiting
Landeskrankenhaus Salzburg | Salzburg, Austria Recruiting
Universitätsklinik für Innere Medizin III der PMU | Salzburg, Austria Recruiting
Medical University of Vienna, Department of Medicine I, Division of Oncology | Vienna, Austria Recruiting
Cliniques universitaires Saint-Luc | Bruxelles, Belgium Recruiting
Grand Hopital de Charleroi | Charleroi, Belgium Recruiting
Universitair Ziekenhuis Antwerpen | Edegem, Belgium Recruiting
Universitair Ziekenhuis Gent UZ Gent | Gent, Belgium Recruiting
Hopital de Jolimont, Rue Ferrer | La Louvière, Belgium Recruiting
UZ Leuven, Radiotherapy & Oncology | Leuven, Belgium Recruiting
Centre Hospitalier de l'Ardenne (CHA) | Libramont, Belgium Active, not recruiting
CHU UCL Namur Site Sainte Elisabeth | Namur, Belgium Recruiting
A.Z. Nikolaas | Sint-Niklaas, Belgium Active, not recruiting
GZA Sint-Augustinus | Wilrijk, Belgium Recruiting
Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela | Barretos, Brazil Recruiting
Hospital de Caridade de Ijui, Avenida David Jose Martins | Ijuí, Brazil Recruiting
Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro | Natal, Brazil Recruiting
Centro Gaúcho Integrado, Rua Costa | Porto Alegre, Brazil Recruiting
Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer | Porto Alegre, Brazil Active, not recruiting
Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer | Porto Alegre, Brazil Recruiting
National Cancer Institute | Rio De Janeiro, Brazil Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC | Santo André, Brazil Recruiting
Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima | São José Do Rio Preto, Brazil Recruiting
Instituto do Cancer do Estado de Sao Paulo (ICESP) | São Paulo, Brazil Recruiting
Oswaldo Cruz German Hospital | São Paulo, Brazil Recruiting
London Regional Cancer Program, London Health Sciences Centre | London, Canada Recruiting
CHU Montréal | Montreal, Canada Recruiting
CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont | Montreal, Canada Active, not recruiting
Hopital Maisonneuve-Rosemont | Montreal, Canada Not yet recruiting
CHU de Quebec-Université Laval | Québec, Canada Recruiting
Sunnybrook Research Institute | Toronto, Canada Recruiting
Beijing Cancer Hospital | Beijing, China Active, not recruiting
Peking Union Medical College Hospital | Beijing, China Active, not recruiting
Jilin Cancer Hospital | Changchun, China Active, not recruiting
Hunan Cancer Hospital | Changsha, China Active, not recruiting
Xiangya Hospital Central South University | Changsha, China Active, not recruiting
West China Hospital of Sichuan University | Chengdu, China Active, not recruiting
Fujian Cancer Hospital | Fuzhou, China Active, not recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou City, China Active, not recruiting
The 2nd Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou, China Active, not recruiting
Zhejiang Province Cancer Hospital | Hangzhou, China Active, not recruiting
Harbin Medical University Cancer Hospital | Harbin, China Active, not recruiting
Lin Yi Cancer Hospital | Linyi District, China Active, not recruiting
Affiliated Tumor Hospital of Guangxi Medical University | Nanning, China Active, not recruiting
Fudan University Shanghai Cancer Center | Shanghai, China Active, not recruiting
Shanghai Ninth People's Hospital | Shanghai, China Active, not recruiting
Shantou University Cancer Hospital | Shantou, China Active, not recruiting
Liaoning Cancer Hospital & institute | Shenyang, China Active, not recruiting
Tianjin Medical University Cancer Institute & Hospital | Tianjin, China Active, not recruiting
Tongji Hospital/Tongji Medical College, Huazhong University of Science | Wuhan, China Active, not recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, China Not yet recruiting
Henan Cancer Hospital | Zhengzhou, China Active, not recruiting
The 5th Affiliated Hospital of Sun yet-sen university | Zhuhai City, China Active, not recruiting
University Hospital hradec Kralové | Hradec Králové, Czechia Recruiting
Fakultni Nemocnice Ostrava | Ostrava-Poruba, Czechia Recruiting
KOC KNTB a.s. Zlín | Zlín, Czechia Recruiting
CHU Amiens Picardie - Hopital Sud | Amiens, France Active, not recruiting
Institut de Cancérologie de l Ouest (ICO) | Angers, France Active, not recruiting
Institut Sainte Catherine | Avignon Cedex 9, France Active, not recruiting
Centre hospitalier Universitaire de Bordeaux | Bordeaux, France Active, not recruiting
CHRU de Brest Hopital Morvan | Brest, France Active, not recruiting
Centre Jean Perrin CLCC | Clermont Ferrand, France Active, not recruiting
CHU de Grenoble | Grenoble Cedex 9, France Active, not recruiting
Centre Guillaume Le Conquerant | le Havre, France Active, not recruiting
Clinique Victor Hugo | Le Mans, France Active, not recruiting
Centre hospitalier Libourne | Libourne, France Active, not recruiting
Centre Oscar Lambret | Lille, France Active, not recruiting
Hôpital du Scorff | Lorient, France Active, not recruiting
Centre Leon Berard | Lyon, France Active, not recruiting
Service d'Oncologie Médicale, CHU Timone | Marseille, France Active, not recruiting
Hôpital Nord Franche Comté | Montbeliard, France Active, not recruiting
Institut Regional du Cancer de Montpellier | Montpellier, France Active, not recruiting
LHopital prive du Confluent Nantes | Nantes Cedex 2, France Active, not recruiting
CCConcorde (GCS) | Neuilly sur Seine, France Active, not recruiting
Centre Antoine Lacassagne | Nice, France Active, not recruiting
CHU Nimes | Nimes, France Active, not recruiting
Institut Curie | Paris, France Active, not recruiting
Centre Eugène Marquis | Rennes Cedex, France Active, not recruiting
Centre Henri Becquerel CLCC | Rouen Cedex, France Active, not recruiting
CHP Saint Gregoire FINESS | Saint Gregoire, France Active, not recruiting
Institut de Cancérologie de l'Ouest - Site Saint Herblain | Saint Herblain, France Active, not recruiting
ICANS | Strasbourg, France Active, not recruiting
Institut Claudius Regaud - IUCT-O | Toulouse, France Active, not recruiting
CHU de Tours | Tours, France Active, not recruiting
The Public Hospital L'Institut de Cancerologie de Lorraine | Vandoeuvre les Nancy, France Active, not recruiting
Institut Gustave Roussy - Service de radiotherapie | Villejuif, France Active, not recruiting
Evex Hospitals Oncology Center | Kutaisi, Georgia Recruiting
Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine | Tbilisi, Georgia Recruiting
Cancer Research Cent 4 | Tbilisi, Georgia Recruiting
Institute of Clinical Oncology | Tbilisi, Georgia Recruiting
JSC "Evex Hospitals" | Tbilisi, Georgia Active, not recruiting
LEPL First University Clinic of Tbilisi State Medical University | Tbilisi, Georgia Recruiting
New Hospitals | Tbilisi, Georgia Recruiting
Simon Khechinashvili University Clinic | Tbilisi, Georgia Recruiting
Charité - Universitätsmedizin Berlin Campus Virchow | Berlin, Germany Active, not recruiting
Strahlenklinik des Uni-Klinikums | Erlangen, Germany Recruiting
Department of radiation oncology, University Hospital Essen | Essen, Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf | Hamburg, Germany Active, not recruiting
Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO | Jena, Germany Recruiting
University Medical Center Schleswig-Holstein, Campus Kiel | Kiel, Germany Active, not recruiting
Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie | Leipzig, Germany Recruiting
Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie | Mannheim, Germany Recruiting
Universitaetsklinikum Regensburg | Regensburg, Germany Active, not recruiting
Universitaetsmedizin Rostock | Rostock, Germany Active, not recruiting
Klinikum der Landeshauptstadt Stuttgart gKAöR | Stuttgart, Germany Recruiting
Agioi Anargiroi General Oncology Hospital of Kifissia | Athens, Greece Recruiting
Attikon University Hospital | Athens, Greece Recruiting
Theagenio Anticancer Hospital | Thessaloníki, Greece Recruiting
Orszagos Onkologiai Intezet Sugarterapias Osztaly | Budapest, Hungary Recruiting
Uzsoki Utcai Korhaz Onkologiai Osztaly | Budapest, Hungary Recruiting
Petz Aladár Megyei Kórház Onkoradiológiai Osztály | Győr, Hungary Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet | Pécs, Hungary Recruiting
Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika | Szeged, Hungary Recruiting
Research Fund of the Hadassah Medical Organization | Ein Kerem, Israel Active, not recruiting
Rambam Healthcare Campus | Haifa, Israel Active, not recruiting
Rabin Medical Center | Petach Tiqva, Israel Active, not recruiting
Sheba Medical Center | Ramat Gan, Israel Active, not recruiting
Centro di Riferimento Oncologico | Aviano, Italy Active, not recruiting
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia | Brescia, Italy Active, not recruiting
Istituto di Candiolo IRCCS | Candiolo, Italy Active, not recruiting
Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle | Cuneo, Italy Active, not recruiting
Azienda Ospedaliero-Universitaria Careggi | Firenze, Italy Active, not recruiting
IRCCS AOU San Martino | Genova, Italy Active, not recruiting
Mater Salutis Hospital AULSS 9 della Regione Venet | Legnago, Italy Active, not recruiting
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola, Italy Active, not recruiting
IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO | Milan, Italy Active, not recruiting
Istituto Nazionale dei Tumori | Milan, Italy Active, not recruiting
Policlinico di Modena | Modena, Italy Active, not recruiting
AOU "Luigi Vanvitelli" | Napoli, Italy Active, not recruiting
Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale" | Napoli, Italy Active, not recruiting
Istituto Oncologico Veneto Irccs | Padova, Italy Active, not recruiting
Azienda Ospedaliero Universitaria di Parma | Parma, Italy Active, not recruiting
UOC Oncologia | Roma, Italy Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli | Rome, Italy Active, not recruiting
ASL2_Presidio Ospedaliero San Paolo | Savona, Italy Active, not recruiting
Hyogo Cancer Center | Akashi-shi Hyogo, Japan Active, not recruiting
National Cancer Center Hospital | Chuo-ku Tokyo, Japan Active, not recruiting
Saitama Medical University International Medical Center | Hidaka-shi Saitama, Japan Active, not recruiting
University Hospital Kyoto Prefectural University of Medicine | Kamigyo-ku, Japan Active, not recruiting
National Cancer Center Hospital East | Kashiwa-shi Chiba, Japan Active, not recruiting
Hokkaido University Hospital | Kita-Ku, Japan Active, not recruiting
Okayama University Hospital | Kita-ku, Japan Active, not recruiting
Cancer Institute Hospital of JFCR | Koto-ku, Japan Active, not recruiting
National Hospital Organization Shikoku Cancer Center | Matsuyama, Japan Active, not recruiting
Shizuoka Cancer Center | Nagaizumi-cho, Japan Active, not recruiting
Pusan National University Hospital | Busan, Korea, Republic of Recruiting
National Cancer Center Hematologic Oncology | Goyang-si, Korea, Republic of Recruiting
National Cancer Center | Goyang-si, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam, Korea, Republic of Recruiting
Asan Medical Center, Asian Cacer Center | Seoul, Korea, Republic of Recruiting
Asan Medical Center | Seoul, Korea, Republic of Recruiting
KonKuk University Medical Center | Seoul, Korea, Republic of Recruiting
Korea University Anam Hospital | Seoul, Korea, Republic of Recruiting
Seoul National University Boramae Medical Center | Seoul, Korea, Republic of Recruiting
Pusan National University Yangsan Hospital, Oncol & Hematology | Yangsan, Korea, Republic of Recruiting
Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii | Gdańsk, Poland Recruiting
Szpitale Pomorskie Sp. z o.o. | Gdynia, Poland Recruiting
Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach | Gliwice, Poland Recruiting
SP ZOZ MSWiA z W-M CO w Olsztynie | Olsztyn, Poland Recruiting
NZOZ Provita Prolife Centrum Medyczne | Łódź, Poland Recruiting
Hospital de Braga | Braga, Portugal Recruiting
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE | Coimbra, Portugal Active, not recruiting
Centro Hospitalar Universitário Lisboa Norte | Lissabon, Portugal Not yet recruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho | Porto, Portugal Recruiting
Centro Hospitalar Universitario São João | Porto, Portugal Not yet recruiting
Hospital Pedro Hispano | Porto, Portugal Recruiting
Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E | Porto, Portugal Recruiting
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan" | Kazan, Russian Federation Active, not recruiting
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky | Krasnoyarsk, Russian Federation Recruiting
Kursk Regional Clinical Oncology Dispensary | Kursk, Russian Federation Recruiting
FGBU N.N.Blokhin Russian Cancer Research Center | Moscow, Russian Federation Recruiting
EuroCityClinic | Saint Petersburg, Russian Federation Recruiting
Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology) | Saint Petersburg, Russian Federation Recruiting
FSBI National Med Research Cancer Center N.N. Petrov | Saint-Petersburg, Russian Federation Recruiting
Republican Clinical Oncological Dispensary of Bashkortostan | Ufa, Russian Federation Recruiting
Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro | A Coruna, Spain Active, not recruiting
Hospital Clinic Barcelona | Barcelona, Spain Active, not recruiting
Hospital Universitari Vall d'Hebron | Barcelona, Spain Active, not recruiting
Institut Català d'Oncologia Badalona | Barcelona, Spain Active, not recruiting
Institut Català d'Oncologia, Hospital Duran | Barcelona, Spain Active, not recruiting
Hospital Reina Sofía | Cordoba, Spain Active, not recruiting
Institut Català d'Oncologia | Girona, Spain Active, not recruiting
Clinica Universidad de Navarra | Madrid, Spain Active, not recruiting
Hospital 12 de Octubre | Madrid, Spain Active, not recruiting
Hospital Ramon y Cajal | Madrid, Spain Active, not recruiting
Hospital Universitario HM Sanchinarro | Madrid, Spain Active, not recruiting
Hospital Universitario La Paz | Madrid, Spain Active, not recruiting
Hospital Civil (Hospital Regional Universitario) | Málaga, Spain Active, not recruiting
Clinica Universidad de Navarra | Pamplona, Spain Active, not recruiting
Hospital Universitario Marqués de Valdecilla. Santander | Santander, Spain Active, not recruiting
Hospital Universitario La Fe | Valencia, Spain Active, not recruiting
IVO | Valencia, Spain Active, not recruiting
Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie | Bern, Switzerland Recruiting
Hopitaux Universitaires de Geneve | Geneve, Switzerland Recruiting
Centre Hospitalier Universitaire Vaudois Lausanne | Lausanne, Switzerland Recruiting
Chang-Gung Memorial Hospital-Kaohsiung | Kaohsiung City, Taiwan Active, not recruiting
Kaohsiung Medical University Memorial Hospital | Kaohsiung, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung City, Taiwan Recruiting
China Medical University Hospital | Taichung, Taiwan Recruiting
National Taiwan University Hospital | Taipei, Taiwan Recruiting
Taipei Veterans General Hospital (VGHTP) | Taipei, Taiwan Recruiting
Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital | Taoyuan City, Taiwan Recruiting
Medical center ASKLEPION LLC | Khodosivka, Ukraine Recruiting
Kiev City Clinical Oncology Centre | Kiev, Ukraine Recruiting
Medical center of Yuriy Spizhenko, Soborna Vulytsia | Kyiv, Ukraine Recruiting
Aberdeen Royal infirmary, Dept. of Oncology | Aberdeen, United Kingdom Recruiting
Royal Marsden NHS Foundation Trust | Chelsea, United Kingdom Recruiting
NHS Greater Glasgow and Clyde | Glasgow, United Kingdom Active, not recruiting
Royal Surrey County Hospital | Guildford, United Kingdom Active, not recruiting
Charing Cross Hospital | London, United Kingdom Active, not recruiting
The Christie NHS Foundation Trust | Manchester, United Kingdom Not yet recruiting
Mount Vernon Cancer Centre | Northwood, United Kingdom Active, not recruiting
Nottingham University Hospitals NHS Trust | Nottingham, United Kingdom Active, not recruiting
University Hospital Southampton NHS Foundation Trust | Southampton, United Kingdom Active, not recruiting
The Royal Marsden NHS Foundation Trust - Sutton | Sutton, United Kingdom Active, not recruiting
Clatterbridge Cancer Centre NHS Foundation Trust | Wirral, United Kingdom Active, not recruiting
Расположение Страны

Argentina

Australia

Austria

Belgium

Brazil

Canada

China

Czechia

France

Georgia

Germany

Greece

Hungary

Israel

Italy

Japan

Korea, Republic of

Poland

Portugal

Russian Federation

Spain

Switzerland

Taiwan

Ukraine

United Kingdom

United States

Дата проверки

2021-12-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • ТрилинX
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Debio 1143

Тип: Experimental

Описание: Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Debio 1143 Monotherapy period (Cycles 4-6): • Debio 1143

Метка: Плацебо

Тип: Активный компаратор

Описание: Участники получат: Сопутствующий период химиолучевой терапии (циклы 1-3): Лучевая терапия Цисплатин Соответствующее плацебо Период монотерапии (циклы 4-6): • Соответствующее плацебо

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное назначение

Первичное назначение: Уход

Маскировка: Четырехместный (участник, поставщик медицинских услуг, исследователь, оценщик результатов)