Clinical trial NCT02178956: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
Official title: A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 714
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, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

Detailed description: The goal of this study is to determine if paclitaxel given together with BBI608 as second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 700 patients will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma.

Patients must have failed first line therapy with any platinum/fluoropyrimidine doublet.

BBI608/placebo will be administered daily, paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.

Eligibility criteria: Inclusion Criteria:

* Cytologically or histologically confirmed advanced gastric or GEJ adenocarcinoma that is metastatic or locally advanced and unresectable.
* Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease.Treatment failure is defined as progression of disease (clinical or radiologic) during first line treatment for unresectable or metastatic disease or ≤ 6 months after last dose of first line treatment.
* Paclitaxel therapy is appropriate for the patient and is recommended by the Investigator.
* Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 21 days prior to randomization. Patients with either measurable disease OR non-measurable evaluable disease will be eligible.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  ･≥ 18 years of age.
* For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 6 months after the final dose of Paclitaxel or for 30 days for female patients and for 90 days for male patients, of the final BBI608/Placebo dose if Paclitaxel was not administered.
* Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
* Alanine transaminase (ALT) ≤ 3 × institutional upper limit of normal (ULN) \[≤ 5 × ULN in presence of liver metastases\] within 14 days prior to randomization.
* Hemoglobin (Hgb) ≥ 9.0 g/dL within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline Hgb assessment.
* Total bilirubin ≤ 1.5 × institutional ULN \[≤ 2.0 x ULN in presence of liver metastases\] within 14 days prior to randomization.
* Creatinine ≤ 1.5 × institutional ULN or Creatinine Clearance \> 50 ml/min (as calculated by the Cockroft-Gault equation) within 14 days prior to randomization.
* Absolute neutrophil count ≥ 1.5 x 10\^9/L within 14 days prior to randomization.
* Platelet count ≥ 100 x 10\^9/L within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline platelet assessment.
* Other baseline laboratory evaluations must be done within 14 days prior to randomization.
* Patient must consent to provision of a representative formalin fixed paraffin block of tumor tissue, if available, in order that the specific correlative marker assays may be conducted.
* Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
* Patients must be accessible for treatment and follow up.
* Protocol treatment is to begin within 2 working days of patient randomization.
* The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.

Exclusion Criteria:

* Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of BBI608/placebo within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of BBI608/placebo.Radiotherapy, immunotherapy, or investigational agents within four weeks of first planned dose of BBI608/placebo, with the exception of a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
* Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting.
* More than one prior chemotherapy regimen administered in the metastatic setting.
* Major surgery within 4 weeks prior to randomization.
* Any known symptomatic brain metastases requiring steroids.
* Women who are pregnant or breastfeeding.
* Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal Investigator, would significantly impede the absorption of an oral agent.
* Unable or unwilling to swallow BBI608/placebo capsules daily.
* Uncontrolled intercurrent illness.
* Peripheral neuropathy ≥ CTCAE Grade 2 at baseline.
* History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.
* Prior treatment with BBI608.
* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
* Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

Primary outcomes:
measure: Overall Survival
timeFrame: 36 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 36 months
measure: Objective Response Rate
timeFrame: 36 months
measure: Disease Control Rate
timeFrame: 36 months
measure: Number of Patients With Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Denver
country: United States
facility: Colorado Cancer Research Program
state: Colorado
city: Goshen
country: United States
facility: Indiana University Health Goshen Center For Cancer Care
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Ochsner NCI CORP
state: Louisiana
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-Minnesota NCI CORP
state: Minnesota
city: Saint Louis
country: United States
facility: Heartland NCORP
state: Missouri
city: Concord
country: United States
facility: New Hampshire Oncology Hematology - Concord
state: New Hampshire
city: Laconia
country: United States
facility: New Hampshire Oncology Hematology - Laconia
state: New Hampshire
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: Indiana University Health University Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center (OUHSC)
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute/ Swedish Health Services
state: Washington
city: Green Bay
country: United States
facility: Saint Vincent Hospital CCOP
state: Wisconsin
city: Green Bay
country: United States
facility: St. Mary's Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield CCOP
state: Wisconsin
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Gosford
country: Australia
facility: Central coast area health (public)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquaries Base Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Riverina Cancer Care Centre
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Nambour
country: Australia
facility: Sunshine Coast Hospital and Health Service
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Hospital
state: Victoria
city: East Bentleigh
country: Australia
facility: Monash Health
state: Victoria
city: East Bentleigh
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Ballarat base hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology and Haematology Services
state: Victoria
city: Subiaco
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Brussel
country: Belgium
facility: UZ Brussel - Campus Jette
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels Capital Region
city: Mons
country: Belgium
facility: CHU Ambroise Paré
state: Hainaut
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
state: Vlaams Brabant
city: Brugge (Assebroek)
country: Belgium
facility: AZ Sint-Lucas - Campus Sint-Lucas
city: Liège
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Salvador
country: Brazil
facility: Oncovida - Centro de Oncologia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Câncer do Ceará - Instituto do Câncer do Cear
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Cetus Hospital Dia Oncologia
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Jaú
country: Brazil
facility: Fundaçao dr Amaral Carvalho
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Inca-RJ
city: São Paulo
country: Brazil
facility: IEP São Lucas
city: São Paulo
country: Brazil
facility: Casa de Saúde Santa Marcelina
city: Sofia
country: Bulgaria
facility: Specialised Hospital for Active Treatment in Oncology
state: Sofia-Grad
city: Pleven
country: Bulgaria
facility: UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
city: Sofia
country: Bulgaria
facility: District Dispensery with Stationary - Sofia District
city: Sofia
country: Bulgaria
facility: Multiprofile hospital for active treatment
city: Sofia
country: Bulgaria
facility: UMHAT"Sv.Ivan Rilski"
city: Varna
country: Bulgaria
facility: Uni. Multiprofile Hospital for Active treatment Sveta Marina
city: Vratsa
country: Bulgaria
facility: COC - Vratsa Dept. of Palliative Care
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital Li Ka Shing Knowledge Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Montreal General Hospital
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: The 307th Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University, Nanfang Hospital
state: Guangdong
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: The 81 Hospital of the Chinese People's Liberation Army
state: Jiangsu
city: Nanjing
country: China
facility: Jiang Su Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Jilin
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xin Jiang Tumor Hospital, Xin Jiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Wuhan
country: China
facility: Tongji Hospital
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
state: Královéhradecký Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Olomoucký Kraj
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Oncology Center
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital Clinic of Hematology and Oncology
state: Tartumaa
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Alpes-Maritimes
city: Marseille
country: France
facility: Hopital Saint Joseph - Marseille
state: Bouches-du-Rhône
city: St Herblain Cedex
country: France
facility: Centre Paul Papin
state: Loire-Atlantique
city: St Herblain Cedex
country: France
facility: Centre Rene Gauducheau
state: Loire-Atlantique
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
state: Rhône
city: La Roche sur Yon Cedex 9
country: France
facility: Chd Vendee La Roche Sur Yon
state: Vendée
city: Poitiers
country: France
facility: Hospital of Poitiers
state: Vienne
city: Brest Cedex
country: France
facility: Hôpital Morvan - CHRU de Brest
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Marseille
country: France
facility: CHU - Hôpital De La Timone
city: Mont de Marsan Cedex
country: France
facility: Centre Hospitalier De Mont De Marsan - Hopital Layné
city: Rennes
country: France
facility: Centre eugène marquis
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Toulouse cedex
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: München
country: Germany
facility: Klinikum Bogenhausen
state: Bayern
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
state: Hessen
city: Bielefeld
country: Germany
facility: Ev. Krankenhaus Bielefeld
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung
state: Nordrhein-Westfalen
city: Maintz
country: Germany
facility: Johannes Gutenberg-Universitaet
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitätsklinik Carl-Gustav-Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Charite - Campus Benjamin Franklin (Cbf)
city: Berlin
country: Germany
facility: Charite
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház
state: Békés
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdú-Bihar
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté
state: Jász-Nagykun-Szolnok
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktato Korhaza
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Beer Sheva
country: Israel
facility: Soroka Medical Center [Oncology]
state: HaDarom
city: Holon
country: Israel
facility: The E. Wolfson Medical Center [Oncology]
state: HaMerkaz
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Organisation
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Meldola
country: Italy
facility: Irccs Irst
state: Forli
city: Faenza
country: Italy
facility: AUSL della Romagna, Osp. degli Infermi
state: Ravenna
city: Ancona
country: Italy
facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
city: Bari
country: Italy
facility: IRCCS Ospedale Oncologico "Giovanni Paolo II"
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi, AOU di Bologna
city: Catania
country: Italy
facility: PO Garibaldi-Nesima, ARNAS Garibaldi
city: Cremona
country: Italy
facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
city: Genova
country: Italy
facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
city: Milano
country: Italy
facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV-IRCCS
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza
city: Ravenna
country: Italy
facility: Unità di Biostatistica e Sperimentazioni Cliniche IRST
city: Torino
country: Italy
facility: Ospedale Molinette, AO Città della Salute e della Scienza di
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Saku
country: Japan
facility: Saku Central Hospital Advanced Care Center
state: Nagano
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kita-Adachi
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospial
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health sciences
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences
state: Kauno Apskritis
city: Panevezys
country: Lithuania
facility: Respublikine Panevezio ligonine
state: Panevežio Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute
state: Vilniaus Apskritis
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto ligonines Santariskiu Klinikos
city: Siauliai
country: Lithuania
facility: Siauliai County Hospital
state: Šiauliu Apskritis
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. F.Lukaszczyka
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie
state: Malopolskie
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Magodent sp. z o.o. Szpital Onkologiczny
state: Mazowieckie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
state: Podkarpackie
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii w Gdansku
state: Pomorskie
city: Poznan
country: Poland
facility: NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika
state: Łódzkie
city: Floresti
country: Romania
facility: Radiotherapy Center CJ radioterapie si chimioterapie adulti
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
state: Dolj
city: Craiova
country: Romania
facility: Oncolab
state: Dolj
city: Baia-Mare
country: Romania
facility: Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare
state: Maramures
city: Timisoara
country: Romania
facility: Oncomed
state: Timis
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara
state: Timis
city: Bucuresti
country: Romania
facility: Med Life
city: Bucuresti
country: Romania
facility: Spitalul Clinic CF 2
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Iasi
country: Romania
facility: Centrul de Oncologie Euroclinic
city: Lasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
state: Bahkortostan, Respublika
city: Saint Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. S.M. Kirov
state: Leningradskaya Oblast'
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N. Blokhin RAMS
state: Moskva
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #40
state: Moskva
city: Perm
country: Russian Federation
facility: GUZ Perm Regional Oncology Dispensary
state: Permskiy Kray
city: Saint Petersburg
country: Russian Federation
facility: Northwestern State Medical University n.a. Mechnikov
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of Saint-Petersburg
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: GBUZ Saint Petersburg clinical scientific and practical cent
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb State Budget Institution Oncology Dispansery
state: Sankt-Petersburg
city: Pyatigorsk
country: Russian Federation
facility: GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
state: Stavropol'skiy Kray
city: Krasnodar
country: Russian Federation
facility: Guz Clinical Oncology Dispensary #1
city: Sevilla
country: Spain
facility: H.U.V. Macarena
state: Andalucía
city: Badalona
country: Spain
facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol
state: Barcelona
city: Avila
country: Spain
facility: C.A.AV-H.Ntra.Sra.de Sonsoles
state: Castilla Y León
city: Majadahonda
country: Spain
facility: H.U.P Hierro-Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: H.del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón
city: Barcelona
country: Spain
facility: H.Sta.Creu i St.Pau
city: Burgos
country: Spain
facility: H.U. de Burgos
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catalá d´Oncología (I.C.O.)
city: Madrid
country: Spain
facility: H.G.U. G. Marañón
city: Madrid
country: Spain
facility: M.D. Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: H.U. R. y Cajal
city: Madrid
country: Spain
facility: H.C. S.Carlos
city: Murcia
country: Spain
facility: H.U.V.Arrixaca
city: Sevilla
country: Spain
facility: H.U.V. del Rocío
city: Valencia
country: Spain
facility: C.H.G.U.de Valencia
city: Zaragoza
country: Spain
facility: H.U. Miguel Servet
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeen City
city: Glasgow
country: United Kingdom
facility: The Beatson West Of Scotland Cancer Centre
state: Glasgow City
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
state: Surrey
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References: