Clinical trial NCT05153239: Clinical Trial of Lurbinectedin As Single-agent or in Combination with Irinotecan Versus Topotecan or Irinotecan in Patients with Relapsed Small-cell Lung Cancer (LAGOON)
Official title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsed Small Cell Lung Cancer
Keywords: Relapsed Small Cell Lung Cancer
PharmaMar
Lurbinectedin
Irinotecan
Topotecan
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, open-label, randomized, controlled
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Detailed description: Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic and pretreated Central Nervous System metastases will be enrolled and assigned to each treatment arm.

Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio.

An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.

Eligibility criteria: Inclusion Criteria:

1. Voluntary written informed consent of the patient obtained before any study-specific procedure
2. Age≥18 years
3. Histologically or cytologically confirmed diagnosis of SCLC.
4. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
5. Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
6. Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
7. Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
8. Adequate hematological, renal, metabolic and hepatic function:

   1. Hemoglobin ≥ 9.0 g/dL \[patients may have received prior red blood cell (RBC) transfusion, if clinically indicated\]; absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L, and platelet count ≥ 100 x 10\^9/L.
   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
   3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
   4. Albumin ≥ 3.0 g/dL.
   5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
9. At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, immune-related hypothyroidism, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
10. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
11. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.

Exclusion Criteria:

1. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
2. Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
3. Active or untreated CNS metastases and/or carcinomatous meningitis.
4. Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
5. Concomitant diseases/conditions:

   1. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
   2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
   3. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
   4. Known Gilbert's disease.
   5. Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
   6. Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
   7. Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
   8. Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
   9. Limitation of the patient's ability to comply with the treatment or to follow the protocol.
   10. Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
   11. Known human immunodeficiency virus (HIV) infection.
   12. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
   13. Evident symptomatic pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
   14. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease).
6. RT in more than 35% of the bone marrow.
7. History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
8. Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines is allowed.
9. Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
10. History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
11. Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use a highly effective method of contraception

Primary outcomes:
measure: Overall survival
timeFrame: From the date of randomization to the date of death or last contact, up to 39 months
Secondary outcomes:
measure: Progression-free survival by IRC (Independent Review Committee)
timeFrame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
measure: Progression-free survival by IA (Investigator Assessment)
timeFrame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
measure: Overall response rate by IRC
timeFrame: From the date of randomization to the date of death or last contact, up to 39 months
measure: Overall response rate by IA
timeFrame: From the date of randomization to the date of death or last contact, up to 39 months
measure: Overall survival rate at 12 months
timeFrame: At 12 months
measure: Overall survival rate at 24 months
timeFrame: At 24 months
measure: Progression-free survival rate at 6 months by IRC
timeFrame: At 6 months
measure: Progression-free survival rate at 6 months by IA
timeFrame: At 6 months
measure: Progression-free survival rate at 12 months by IRC
timeFrame: At 12 months
measure: Progression-free survival rate at 12 months by IA
timeFrame: At 12 months
measure: Duration of response by IRC
timeFrame: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
measure: Duration of response by IA
timeFrame: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
measure: Patient-reported outcomes
timeFrame: At baseline and every six weeks (± one week) until end of treatment, up to 39 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer and Blood
state: Arkansas
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - Panhandle
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Joliet
country: United States
facility: Duly Health and Care
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institue, Downtown
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Grand Island
country: United States
facility: Oncology Hematology West, PC (Grand Island)
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists
state: Nebraska
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: The Chris Obrien Lifehouse
state: New South Wales
city: Ballarat Central
country: Australia
facility: BRICC - Ballarat Health Services
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital Eastern Health Clinical School
state: Victoria
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
city: Gosford
country: Australia
facility: Gosford Hospital GH - Central Coast Cancer Centre
city: Heidelberg
country: Australia
facility: Austin Hospital- Medical Oncology Unit
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
city: Wollongong
country: Australia
facility: Cancer Care Wollongong
city: Salzburg
country: Austria
facility: University Hospital Salzburg
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien CHC - MontLegia
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Liège
country: Belgium
facility: CHU Liege
city: Mechelen
country: Belgium
facility: Az Sint Maarten Mechelen
city: Mons
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) Ambroise Pare
city: Curitiba
country: Brazil
facility: Oncocentro-Centro de Oncologia do Parana
state: Parana
city: Santa Cecília
country: Brazil
facility: UPCO - Hospital de Clinicas de Porto Alegre
state: Porto Alegre
city: Ondina
country: Brazil
facility: Nucleo de Oncologia da Bahia - NOB
state: Salvador
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
city: Ijuí
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
city: Porto Alegre
country: Brazil
facility: Irmandade daSanta Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - Ministrio da Sade
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
city: Sofia
country: Bulgaria
facility: Specialized hospital for active treatment of oncological diseases
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
city: Hamilton
country: Canada
facility: Hamilton Health Sciences -Juravinski Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Laval
country: Canada
facility: Hôpital de la Cité-de-la- Santé
state: Quebec
city: Longueuil
country: Canada
facility: CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC)
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer
state: Araucania
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
state: Los Ríos
city: Santiago de Chile
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Santiago de Chile
country: Chile
facility: Clinica Alemana de Santiago
city: Santiago de Chile
country: Chile
facility: Clínica Santa María
city: Santiago de Chile
country: Chile
facility: Fundación Arturo López Pérez
city: Santiago de Chile
country: Chile
facility: Hospital Clinico Universidad de Chile
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Næstved
country: Denmark
facility: Sjællands Universitetshospital
city: Sønderborg
country: Denmark
facility: Sønderborg Sygehus
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Boulogne-Billancourt
country: France
facility: AssAP-HP - Hopital Ambroise-Pare
city: Brest
country: France
facility: Hopital Morvan CHU de Brest
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU de Caen - Hopital Cote de Nacre
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil (CHIC)
city: Limoges
country: France
facility: Centre Hospitalier Universitaire CHU De Limoges
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
city: Reims
country: France
facility: CHU Reims - Hpital Maison Blanche
city: Strasbourg
country: France
facility: Hopital Civil / Nouvel Hopital Civil
city: Suresnes
country: France
facility: Hospital Foch
city: Villejuif
country: France
facility: Gustave Roussy
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: Todua Clinic
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Institute Of Clinical Oncology
city: Tbilisi
country: Georgia
facility: JSC Evex Hospitals "Caraps Medline"
city: Tbilisi
country: Georgia
facility: LTD Cancer Research Centre
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf
state: Schleswig Holstein
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Bremen
country: Germany
facility: Klinikum Bremen Ost
city: Duisburg
country: Germany
facility: Helios St. Johannes Klinikum
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Freiburg
country: Germany
facility: Universittsklinikum Freiburg
city: Gauting
country: Germany
facility: Asklepios Fachklinik München-Gauting
city: Halle (saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle gGmbH
city: Halle
country: Germany
facility: Universitaetsklinikum Halle Saale
city: Heidelberg
country: Germany
facility: Thoraxclinic Heidelberg GmbH
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG Karlsruhe
city: Kassel
country: Germany
facility: Klinikum Kassel - Medizinische Klinik IV
city: Löwenstein
country: Germany
facility: Klinik Loewenstein gGmbH
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim
city: München
country: Germany
facility: Staedtisches Klinikum München - Bogenhausen
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Debrecen
country: Hungary
facility: Debreceni Egyetem - Klinikai Kozpont
city: Farkasgyepű
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun County Hospital
city: Szolnok
country: Hungary
facility: Hetenyi G Korhaz, Onkologiai Kozpont
city: Törökbálint
country: Hungary
facility: Pulmonology Hospital Torokbalint
city: Haifa
country: Israel
facility: Rambam Health Care Campu
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
city: Catania
country: Italy
facility: Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle, Ospedale Carle
city: Florence
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: ASL 3 Genovese Oncologia Medica Villa Scassi
city: Milan
country: Italy
facility: IRCCS Istituto Clinico Humanitas - Cancer Center
city: Napoli
country: Italy
facility: Universita degli Studi della Campania Luigi Vanvitelli
city: Novara
country: Italy
facility: Ospedale Maggiore di Novara
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
city: Padova
country: Italy
facility: Oncologia Medica II Istituto Oncologico Veneto IRCCS
city: Piacenza
country: Italy
facility: Azienda USL di Piacenza
city: Rionero In Vulture
country: Italy
facility: Irccs-Crob
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: IFO Regina Elena
city: Sondrio
country: Italy
facility: ASST Valtellina e Alto Lario Ospedale di Sondrio
city: Varese
country: Italy
facility: ASST Sette Laghi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Ohara HealthCare Foundation Kurashiki Central Hospital
state: Okayama
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka-Fu
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Izumi
country: Japan
facility: Izumi City General Hospital
state: Osaka
city: Izumi
country: Japan
facility: Kanagawa Cancer Center
state: Osaka
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
state: Osaka
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vincents Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
city: Białystok
country: Poland
facility: II Klinika Chorob Pluc i Gruzlicy
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
city: Lublin
country: Poland
facility: Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Sp. z o.o
city: Rzeszów
country: Poland
facility: Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
city: Tomaszów Mazowiecki
country: Poland
facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii
city: Baia Mare
country: Romania
facility: Sc Oncopremium Team Srl
city: Cluj-Napoca
country: Romania
facility: Medisprof srl
city: Craiova
country: Romania
facility: Oncolab SRL
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantu Nectarie
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital
city: Timişoara
country: Romania
facility: Oncocenter Oncologie clinica S.R.L
city: Badalona
country: Spain
facility: Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Materno-Insular de Gran Canaria
state: Gran Canaria
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
state: Pontevedra
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera C.H.U.A.
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Málaga
country: Spain
facility: Hospital Regional Universitario Málaga Hospital Civil
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Bleza
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana
city: Frauenfeld
country: Switzerland
facility: Spital Thurgau - Kantonspital Frauenfeld
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Münsterlingen
country: Switzerland
facility: Spital Thurgau - Kantonsspital Muensterlingen
city: Villars-sur-Glâne
country: Switzerland
facility: HFR Freiburg Kantonsspital
city: Dalin
country: Taiwan
facility: Buddhist Dalin Tzu Chi Hospital
state: Chiayi
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
city: Seyhan
country: Turkey
facility: Medicalpark Seyhan Hospital
state: Adana
city: Çankaya
country: Turkey
facility: Liv Hospital Ankara
state: Ankara
city: Bagcilar
country: Turkey
facility: Bagcilar Medipol Mega University Hospital
state: Istambul
city: Kadıköy
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
state: Istambul
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Wirral
country: United Kingdom
facility: Clatterbridge Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
References: