Clinical trial NCT02273375: Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
Official title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: Intergroupe Francophone de Cancerologie Thoracique
name: Thoracic Oncology Group of Australasia (TOGA)
name: National Health and Medical Research Council, Australia
name: National Cancer Institute (NCI), Naples
name: Central and Eastern European Oncology Group
name: Dutch Society of Physicians for Pulmonology and Tuberculosis
name: Korean Cancer Study Group
name: Fundación GECP
name: West Japan Oncology Group (WJOG)
name: Chinese Thoracic Oncology Group
First posted: 2014-10-24
Enrollment: 1415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
* Patients must be classified post-operatively as Stage IB (≥ 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Note: Although T3N2M0 tumours have been reclassified to stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as stage IIIA under the 7th edition criteria).

  * Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques

Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status.

Prior Systemic Therapy:

* Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
* Patients may have received prior post-operative platinum based chemotherapy as per standard of care.
* No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible.

Radiation:

• Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.

* The patient must have an ECOG performance status of 0, 1.
* Hematology: . Absolute neutrophil count ≥ 1.5 x 109/L or ≥ 1,500/µl Platelets ≥ 100 x 109/L or ≥ 100,000/µl
* Biochemistry:

Total bilirubin\* ≤ institutional upper limit of normal Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) ≤ 2.5 x institutional upper limit of normal Creatinine Clearance ≥ 40 ml/min

\* excluding Gilbert's syndrome

Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:

Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L

* Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
* Protocol treatment is to begin within 2 working days of patient randomization

Exclusion Criteria:

* Patients with a history of other malignancies, except:

  * adequately treated non-melanoma skin cancer,
  * curatively treated in-situ cancer, or
  * other malignancies curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
* A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).
* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded.
* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization\* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
* Live attenuated vaccination administered within 30 days prior to randomization.
* History of hypersensitivity to MEDI4736 or any excipient.
* Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF \> 50% within 12 weeks prior to randomization.
* Concurrent treatment with other investigational drugs or anti-cancer therapy.
* Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:

  * known clinical diagnosis of tuberculosis;
  * known active hepatitis B infection (positive HBV surface antigen (HBsAg)). Patients with a past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBSAg) are eligible;
  * known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;
  * known human immunodeficiency virus infection (positive HIV antibodies).
  * known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function
* Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception.

Primary outcomes:
measure: Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and patients without common activating EGFR mutations or ALK gene rearrangements
timeFrame: 6.7 years
Secondary outcomes:
measure: Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
timeFrame: 8 years
measure: Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
timeFrame: 8 years
measure: Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
timeFrame: 8 years
measure: Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
timeFrame: every 6 months
measure: Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
timeFrame: 8 years
measure: Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
timeFrame: 8 years
measure: Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
timeFrame: 8 years
measure: Evaluate the predictive/prognostic significance of PD-L1 expression
timeFrame: 8 years
measure: Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
timeFrame: 8 years
measure: Explore polymorphisms that may be associated with outcomes
timeFrame: Baseline only
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: USC Norris/Comprehensive Cancer Centre
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dunmore
country: United States
facility: Hematology and Oncology Associates of NEPA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: West Reading
country: United States
facility: The Reading Hospital Medical Center
state: Pennsylvania
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Habour Health Campus - NCCI
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Hospital, Cancer Care Centre
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Cancer Therapy Centre, Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute St Leonards
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Brisbane
country: Australia
facility: Mater Medical Centre
state: South, QLD
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital - Peninsula Oncology Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital Research Foundation
state: Victoria
city: Richmond
country: Australia
facility: Epworth HealthCare - Richmond
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Subiaco
state: Western Australia
city: Adelaide
country: Australia
facility: Flinders Medical Center
city: Garran
country: Australia
facility: Canberra Hospital
city: Victoria Park
country: Australia
facility: St. Vincent's Hospital
city: Fortaleza
country: Brazil
facility: Suporte Nutricional e Quimioterapia LTDA PRONUTRIR
state: Ceara
city: Cachoeiro de Itapemirim
country: Brazil
facility: Hospital Evangelico de Cachoeiro de Itapemirim
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Cetus Hospital Dia Oncologia
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer
state: Rio Grande Do Norte
city: Bento Goncalves
country: Brazil
facility: Instituto Tacchini de Pesquisa em Saude
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro de Oncologia e Radioterapia (COR) Mae de Deus
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina do ABC
state: Santo Andre
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer (INCA)
city: Sofia
country: Bulgaria
facility: MHAT Serdika - Medical Oncology Clinic
city: Sofia
country: Bulgaria
facility: MHAT Nadezhda Hospital
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Abbotsford
country: Canada
facility: BCCA - Abbotsford Centre
state: British Columbia
city: Surrey
country: Canada
facility: BCCA - Fraser Valley Cancer Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BCCA - Vancouver Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Saint John
country: Canada
facility: Regional Health Authority B, Zone 2
state: New Brunswick
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre at Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Health Centre at Southlake
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Algoma District Cancer Program
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre/Thunder
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Charlottetown
country: Canada
facility: PEI Cancer Treatment Centre
state: Prince Edward Island
city: Levis
country: Canada
state: Quebec
city: Montreal
country: Canada
facility: CHUM-Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: The Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: The Research Institute of the McGill University
state: Quebec
city: Montreal
country: Canada
facility: Centre Integre Universitaire De Sante Et De Services
state: Quebec
city: Quebec City
country: Canada
facility: University Institute of Cardiology and
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hosp of Shantou Medical Colleg
state: Guangdong
city: Nanning
country: China
facility: The People Hospital of Guangxi Zhuang Autonomous Reg
state: Guangxi
city: Zhengzhou
country: China
facility: Henan province Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South Univer
state: Hunan
city: Yueyang
country: China
facility: The First People Hospital of Yueyang
state: Hunan
city: Nanjing
country: China
facility: Nanjing General Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital Of Xuzhou Medical College
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People Hospital
state: Jiangsu
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Kunming
country: China
facility: Yunnan Provincial Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Sir run run shaw hospital School of Medicine
state: Zhejiang
city: Marseille Cedex
country: France
facility: CRLCC - Paoli-Calmette
state: BP
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
state: Cedex 04
city: Montpellier
country: France
facility: Centre hospitalier universitaire de Montpellier
state: Cedex 05
city: Paris
country: France
facility: AP-HP Hopital Tenon
state: Cedex 20
city: Grenoble
country: France
facility: Hopital Albert Michallon
state: Cedex 9
city: Tours Cedex
country: France
facility: CHRU de Tours - Hopital Bretonneau
state: Tours Cedex 9
city: Angers
country: France
facility: CHU - Angers
city: Avignon
country: France
facility: Centre Hospitalier - Avignon
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Bayonne - Centre Hospitalier
city: Besancon Cedex
country: France
facility: Hopital Jean Minjoz
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Boulogne
country: France
facility: Boulogne - Ambroise Pare
city: Caen
country: France
facility: Caen - CHU
city: Chambery
country: France
facility: Centre Hospitalier de Chambery
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Clamart
country: France
facility: HIA Percy
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand - CHU
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Contamine Sur Arve
country: France
facility: Annemasse - Centre Hospitalier Alpes Leman
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Dijon
country: France
facility: CHU Hopital du Bocage
city: Elbeuf
country: France
facility: Centre Hospitalier Intercommunal - Elbeuf
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier departemental
city: Le Chesnay
country: France
facility: Versailles - CH Andre Mignot
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: Lille - Hopital Calmette
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Macon
country: France
facility: Centre Hospitalier les Chanaux
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Marseille - Hopital Nord
city: Metz-Tessy
country: France
facility: CH de la Region d'Annecy
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Nice
country: France
facility: Centre Antoine Lacassagne - Nice
city: Orleans
country: France
facility: Centre Hospitalier Regional Hopital de la Source
city: Paris Cedex 5
country: France
facility: Paris - Institut Curie
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Fondation Hopital Saint Joseph
city: Paris
country: France
facility: Paris - HEGP
city: Paris
country: France
facility: Hopital Bichat
city: Pau
country: France
facility: Centre Hospitalier General de Pau
city: Perigueux
country: France
facility: Centre Hospitalier de Perigueux
city: Pontoise
country: France
facility: Centre Hospitalier Rene Dubos
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-priest-en-jarez
country: France
facility: Institut de Cancerologie de la Loire
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin
city: Strasbourg
country: France
facility: Nouvel Hopital Civil Hopitaux
city: Suresnes
country: France
facility: Suresnes - Foch
city: Thonon Les Bains
country: France
facility: Thonon-les-Bains - Hopital Georges Pianta
city: Toulon
country: France
facility: CHITS Toulon Sainte Musse
city: Toulouse
country: France
facility: Hopital Larrey
city: Villefranche Sur Saone
country: France
facility: Villefranche sur Saone - CH
city: Budapest
country: Hungary
facility: Semmelweis University Pulmonology Department
city: Torrette
country: Italy
facility: AOU Ospedali Riuniti Umberto I
state: AN
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
state: AV
city: Bari
country: Italy
facility: IRCCS Ospedale Oncologico Giovanni Paolo II
state: BA
city: Rozzano (MI)
country: Italy
facility: Instituto Clinico Humanitas
state: Lombardia
city: Milano
country: Italy
facility: Ospedale S. Paolo - U.O. di Oncologia Medica
state: MI
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Santa Maria
state: PG
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - CRO
state: PN
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri Oncologia Medica
state: PV
city: Ravenna
country: Italy
facility: OUC Oncologia Medica - Presidio Ospedaliero
state: RA
city: Reggio Emilia
country: Italy
facility: Oncologia Medica IRCCS Arcispedale Maria
state: RE
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri IFO Istituto
state: RM
city: Saronno
country: Italy
facility: A.O. Busto Arsizio - P.O. Saronno
state: VA
city: Verona
country: Italy
facility: AOU Integrata Verona Policlinico GB
state: VR
city: Benevento
country: Italy
facility: U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
city: Brindisi
country: Italy
facility: PO A Perrino ASL Brindisi - UOC Oncologia Medica
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele UOC di Oncologia
city: Genova
country: Italy
facility: U.O. di Oncologia Ospedale Villa Scassi
city: Meldola
country: Italy
facility: Intstituto Scientifico Romangnolo
city: Milan
country: Italy
facility: European Institute of Oncology
city: Mirano
country: Italy
facility: U.O.C. di Oncologia U.L.S.S. 13
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale
city: Napoli
country: Italy
facility: Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
city: Napoli
country: Italy
facility: Unita Sperimentazioni Cliniche Istituto per lo
city: Napoli
country: Italy
facility: Universita Federico II UOC Oncologia Medica
city: Padova
country: Italy
facility: UOC Oncologia Medica II Instituto Oncologio Veneto
city: Piacenza
country: Italy
facility: Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
city: Rome
country: Italy
facility: Azienda Ospedaliera S. Camillo-Forlanin
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu Univiesity Hospital
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Kobe-shi
country: Japan
facility: Koube University Hospital
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine
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: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-Sayama
country: Japan
facility: Kinki University Hospital Faculty of Medicine
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo
state: Osaka
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Yokohama City
country: Japan
facility: Kanagawa Cancer Center
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk Do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Dalseogu
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
state: Dongjak Gu
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
state: Gangdong-gu
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon
state: Gyeonggi Do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi Do
city: Gyeonggi-do
country: Korea, Republic of
facility: Uijeongbu ST Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea,
city: Nijmegen
country: Netherlands
facility: Universitair medisch centrum Nijmegen st Radboud
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: Noord Brabant
city: Hilversum
country: Netherlands
facility: Tergooi locatie Hilversum
state: Noord Holland
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Amsterdam
country: Netherlands
facility: Free University Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Maastricht
country: Netherlands
facility: Academical Hospital Maastricht
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center (EMC)
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Gdansk
country: Poland
facility: Klinika Onkologii i Radioterapii Uniwersyteckie
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im
city: Zakopane
country: Poland
facility: Samodzielny Publiczny Szpital Specjalistyczny
city: Bucharest
country: Romania
facility: Conformal Med Terra HIFU
city: Bucharest
country: Romania
facility: Spitalul de Psihiatrie Dr. Constantin Gorgos
city: Bucharest
country: Romania
facility: Oncology Institute Bucharest
city: Cluj-Napoca
country: Romania
facility: Oncological Institute "Ion Chiricuta"
city: Constanta
country: Romania
facility: OCH - Ovidius Clinical Hospital
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie
city: Craiova
country: Romania
facility: SC Oncolab SRL
city: Ploiesti
country: Romania
facility: Spital Lotus SRL
city: Singapore
country: Singapore
facility: National University Hospital
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Las Palmas
country: Spain
facility: Hospital Insular de Gran Canaria
state: Gran Canaria
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hoapital Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Vall d Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Coruna
country: Spain
facility: Hospital Teresa Herrera
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: New Taipei City;
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taiwan;
city: Chiayi City
country: Taiwan
facility: Chang-Gung Memorial Hospital - Chiayi
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
city: Kaohsiung
country: Taiwan
facility: Chang-Gung Memorial Hospital - Kaohsiung
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital - Taipei
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital - Linkou
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Clinical Hospital No.4
city: Sumy
country: Ukraine
facility: Regional Oncology Center
city: Vinnitsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncology Dispensary
Study officials:
affiliation: Ottawa Hospital Research Institute, Ontario, Canada
name: Glenwood Goss
role: STUDY_CHAIR
References: