Clinical trial NCT02993731: A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Official title: A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Endocrine Gland Neoplasms
Pancreatic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Gemcitabine
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 1134
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: This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
2. Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
3. Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered \> 6 months prior to randomization and no lingering toxicities are present.
4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed \< 14 days prior to randomization.
6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
7. Must have life-expectancy of \> 12 weeks.
8. Must be ≥ 18 years of age. Due to increased risk of sepsis in patients \>80 years old, candidate patients in this age group should be thoroughly evaluated prior to study randomization to ensure they are fit to receive chemotherapy. In addition to all of the inclusion/exclusion criteria listed, clinical judgment should be used regarding patients' susceptibility to infection (including but not limited to presence of ascites or diabetes mellitus increasing risk of infection). Furthermore, the expected stability of their performance status while receiving repeat weekly chemotherapy cycles should be given special attention. Patients in this age group should not be randomized on the study should there be any hesitation on any of these considerations.
9. For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
11. Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization):

    1. Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
    2. Platelet count \> 100,000/mm\^3 (100 x 10\^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.
    3. Hemoglobin (HgB) \> 9 g/dL. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
12. Patient has the following blood chemistry levels at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization):

    1. AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) \[≤ 5 × ULN in presence of liver metastases\]
    2. Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is \> ULN and \< 1.5 x ULN, it must be non-rising for at least 7 days.
    3. Serum creatinine within normal limits or calculated clearance \> 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) \> 30 kg/m\^2, lean body weight should be used instead.
13. Patient not on anticoagulation has acceptable coagulation studies (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%).

    Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.
14. Patient has no clinically significant abnormalities on urinalysis results (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization).
15. Patient must have adequate nutritional status with Body Mass Index (BMI) \> 18 kg/m\^2 and body weight of \> 40 kg with serum albumin \> 3 g/dL.
16. Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated \< 72 hours prior to randomization.
17. Patients requiring biliary stent placement must have biliary stent placed \> 7 days prior to screening.
18. Pain symptoms should be stable (of tolerable Grade 2 or less).
19. Only patients with available archival tumor tissue must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays (Correlative Studies) of this protocol may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block and 5-20 unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block, 5-20 unstained slides of representative tumor tissue are also acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study.
20. Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted.
21. Patients must be accessible for treatment and follow up. Patients registered on this trial must receive protocol treatment and be followed at the participating center. This implies there must be reasonable geographical limits placed on patients being considered for this trial. Investigators must ensure that the patients randomized on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.
22. Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization.
23. 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:

1. Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
2. Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
3. Patient has a \> 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
4. Patient has a \> 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.
5. Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.

   1. Patients receiving immunotherapy for non-cancer related treatment within \< 4 weeks of first planned dose of study treatment will be excluded.
   2. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered \> 6 months prior to randomization.
6. Major surgery within 4 weeks prior to randomization.
7. Any known brain or leptomeningeal metastases are excluded, even if treated.
8. Patients with clinically significant ascites or pleural effusions.
9. Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.
10. Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
11. Unable or unwilling to swallow napabucasin capsules daily.
12. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.

    1. History of cardiac disease: congestive heart failure (CHF) \> New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction or coronary stenting within 6 months prior to randomization; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    2. Current uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
    3. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease including claudication, Leo Buerger's disease). Treated peripheral vascular disease that is stable for at least 6 months is allowed.
    4. Evidence of bleeding diathesis or clinically significant coagulopathy.
    5. Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to randomization.
    6. Patients with clinically significant abnormalities on urinalysis at \< 14 days prior to randomization.
    7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
    8. Ongoing serious, non-healing wound, ulcer, or bone fracture.
    9. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection with hepatitis B, or hepatitis C.
    10. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
    11. History of hemolytic-uremic syndrome.
    12. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
    13. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.
13. Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics or Prescribing Information. Possible hypersensitivity to napabucasin or one of the excipients which include the azo dyes sunset yellow and allura red.
14. Neurosensory neuropathy \> grade 2 at baseline.
15. Uncontrolled chronic diarrhea \> grade 2 at baseline.
16. Patients being treated with Warfarin.
17. Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
18. Patients with a 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 by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for \> 5 years.
19. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 14 or more consecutive days during the course of the study are ineligible.

Primary outcomes:
measure: Overall Survival
timeFrame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
measure: Disease Control Rate
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
measure: Overall Response Rate
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
measure: Number of Patients With Adverse Events
timeFrame: Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
measure: Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
timeFrame: 8 weeks
Other outcomes:
measure: Overall Survival in Biomarker Positive Patients
timeFrame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
measure: Progression Free Survival in Biomarker Positive Patients
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
measure: Disease Control Rate in Biomarker Positive Patients
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
measure: Overall Response Rate in Biomarker Positive Patients
timeFrame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute (CCI)
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association DBA Torrance Memorial
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center Santa Monica Hematology And Oncology
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo Medical Center
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center
state: Connecticut
city: Norwalk
country: United States
facility: The C Anthony and Jean Whittingham Cancer Center
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center (GUMC)
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center - Orlando Health
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists North
state: Florida
city: Wellington
country: United States
facility: Florida Cancer Specialists East Region
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Health System
state: Idaho
city: Evanston
country: United States
facility: NorthShore University Health Systems
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center CCOP
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Regional Medical Group
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Physician Group (PPG)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University - Melvin and Bren Simon Cancer
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Cancer Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Hematology Oncology Associates (LHOA)
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine - Scarborough
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital of Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro MN Clinical Oncology Research Consortium
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri - Ellis Fischel Cancer Cent
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: HCA Midwest Division (Kansas City)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic - Cancer & Hematology
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: UNM Cancer Research and Treatment Center
state: New Mexico
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Cancer Center
state: New York
city: Cooperstown
country: United States
facility: Basset Medical Center
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates PC
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine/ NewYork-Presbyterian
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill / Lineberger Comprehensive Cancer
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center (GCC) - Canton Facility
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Centers
state: Ohio
city: Lawton
country: United States
facility: Cancer Center of Southwest Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology and Hematology - McAuley
state: Oklahoma
city: Hillsboro
country: United States
facility: Kaiser Permanente - Westside Medical Office
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center (FCCC) - Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Medical Group
state: South Dakota
city: Chattanooga
country: United States
facility: Tennessee Oncology Chattanooga
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: SCRI - Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Midlothian
country: United States
facility: Bon Secours Cancer Institute Medical Oncology
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia
state: Virginia
city: Everett
country: United States
facility: The Everett Clinic
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Mary Babb Randolph Cancer Center (MBRCC)
state: West Virginia
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Green Bay Oncology, Ltd. - West Green Bay
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center - Vince Lombardi
state: Wisconsin
city: East Albury
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: ICON Cancer Care
state: South Australia
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
city: East Albury
country: Australia
facility: Border Medical Oncology
city: Heidelberg
country: Australia
facility: The Austin Hospital
city: Malvern
country: Australia
facility: Cabrini Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
city: South Brisbane
country: Australia
facility: ICON Cancer Care
city: Sydney
country: Australia
facility: Macquarie University Hospital
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Graz
country: Austria
facility: LKH Universitätsklinikum Graz
city: Innsbruck
country: Austria
facility: Landeskrankenhaus Medical University Innsbruck
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Salzburg
country: Austria
facility: Universitatsklinik far Innere Medizin III
city: Vienna
country: Austria
facility: Medical University Vienna
city: Bruxelles
country: Belgium
facility: ULB Erasme
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Gent
country: Belgium
facility: UZ Ghent
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liege
city: Yvoir
country: Belgium
facility: CHU Dinant Godinne
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: The Atlantic Clinical Cancer Research Unit (ACCRU)
state: Nova Scotia
city: Pointe-Claire
country: Canada
facility: Centre Hospitalier de St. Mary
state: Quebec
city: Trois-Rivières
country: Canada
facility: Ciusssmcq
state: Quebec
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Toronto
country: Canada
facility: University of Toronto - St. Michael's Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changchun
country: China
facility: The first hospital of jilin university
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Shaw Hospital School of Medicine Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
city: Nanjing
country: China
facility: The 81 Hospital of the Chinese Peoples Liberation Army
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Ren Ji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: East Hospital of Tongji University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Benešov
country: Czechia
facility: Onkologicke oddeleni
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno Interni hematoonkologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Zlín
country: Czechia
facility: Onkologické oddělení
city: Amiens
country: France
facility: Hôpital Sud - CHU Amiens Picardie
city: Chambray-lès-Tours
country: France
facility: Hôpital Trousseau, CHRU de Tours
city: Lyon Cedex 03
country: France
facility: Hopital Edourard Herriot
city: Nantes Cedex 1
country: France
facility: CHU-Hôtel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Strasbourg
country: France
facility: Clinique Saint Anne
city: Strasbourg
country: France
facility: Hopital Civil de strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: Institute de Cancerologie de Lorraine
city: Amberg
country: Germany
facility: Gesundheitszentrum St. Marien GmbH
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Frankfurt am main
country: Germany
facility: Krankenhaus Nordwest
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: München
country: Germany
facility: Klinikum Bogenhausen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR - UK für Innere Medizin
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Candiolo
country: Italy
facility: Istituto Ricerca e la Cura del Cancro (IRCC)
city: Catanzaro
country: Italy
facility: AOU Mater Domini
city: Faenza
country: Italy
facility: Ospedale degli Infermi
city: Feltre
country: Italy
facility: Santa Maria de Prato Hospital
city: Meldola
country: Italy
facility: IRCCS - Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Perugia
country: Italy
facility: AO SM Misericordia
city: Reggio Emilia
country: Italy
facility: IRCCS Azienda Ospedaliera S.Maria Nuova
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Torino
country: Italy
facility: Dermatological Hospital San Lazzaro
city: Varese
country: Italy
facility: ASST Settelaghi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Bunkyō-Ku
country: Japan
facility: University of Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hopsital
state: Tokyo
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul national University Bundang Hospital
city: Jeongnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden (MCL)
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Zwolle
country: Netherlands
facility: Isala Ziekenhuis
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED
city: Lublin
country: Poland
facility: Klinika Chirurgii Onkologicznej
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
city: Poznań
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Toruń
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Lisboa
country: Portugal
facility: Fundação Champalimaud
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E
city: Porto
country: Portugal
facility: IPO Porto Francisco Gentil, E.P.E.
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar Entre Douro e Vouga
city: Kislino
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
state: Kursk
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Cheboksary
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Llc Evimed
city: Chelyabinsk
country: Russian Federation
facility: Railway Clinical Hospital on station Chelyabinsk
city: Kazan
country: Russian Federation
facility: Republic Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsk District Medical Center
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg Medical Universitet n.a. I.P. Pavlov
city: Saint Petersburg
country: Russian Federation
facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies"
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Samara
country: Russian Federation
facility: Multi-type clinic 'REAVIZ'
city: Saransk
country: Russian Federation
facility: National Research Mordovia State University
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: (ICO) Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: LinKou Chang Gung Memorial Hospital
city: Kharkiv
country: Ukraine
facility: Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine
city: Kyiv
country: Ukraine
facility: National Institute of Cancer
Study officials:
References: