Clinical trial NCT05611931: Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometrial Cancer
Keywords: Selinexor
KPT-330
Advanced or Recurrent Endometrial Carcinoma
XPORT-EC
ENGOT-EN20
GOG-3083
XPORT-EC-042
p53 wild-type
Tumor protein 53 wild-type
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: Belgian Gynaecological Oncology Group
name: North Eastern German Society of Gynaecological Oncology
name: Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies
name: Spanish Research Group in Ovarian Cancer
name: The Central and Eastern European Gynecologic Oncology Group
name: Israeli Society of Gynecologic Oncology
name: Australia New Zealand Gynaecological Oncology Group
First posted: 2022-11-10
Enrollment: 220
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 evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age at the time of signing informed consent.
* Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
* TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor.
* Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The participants should have received treatment for:

Primary Stage IV disease, defined as:

* had a primary or later debulking surgery during first-line platinum-based therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum-based therapy, OR
* had a primary or later debulking surgery during first-line platinum-based therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy

OR

At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapy for Stage I-IV disease), defined as:

* had Stage I - III disease at diagnosis and received, at initial diagnosis, adjuvant chemotherapy and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse,
* had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse.

  * Previous treatment with anti-programmed cell death protein 1(PD-1) or anti-programmed death-ligand 1(PD-L1) monoclonal antibody and concomitant biologic agents (e.g., bevacizumab, trastuzumab) is allowed.
  * Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of chemotherapy.
  * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  * Participants must have adequate bone marrow function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria:
* Hepatic function: total bilirubin up to less than (\&lt;) 3\*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\&lt;=) 2.5\*ULN in participants without liver metastasis. For participants with known liver involvement of their tumor: AST and ALT (\&lt;=) 5\*ULN
* Hematopoietic function within 1 week: Absolute neutrophil count (ANC) greater than or equal to (\&gt;=) 1.5\*10\^9/liter (L); platelet count \&gt;= 100\*10\^9/L; hemoglobin \&gt;= 9.0 gram per deciliter (g/dL) per local laboratory results
* Renal function: estimated creatinine clearance (CrCl) of \&gt;= 20 milliliter per minute (mL/min), calculated using the standard local formula, as applicable

  - In the opinion of the Investigator, the participant must:
* Have a life expectancy of at least 12 weeks, and
* Be fit to receive investigational therapy

  * Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 90 days following the last dose of study drug.
  * Written informed consent signed in accordance with federal, local, and institutional guidelines prior to the first screening procedure.

Exclusion Criteria:

* Participants meeting any of the following exclusion criteria are not eligible to enroll in this study:
* Has any uterine sarcomas (carcinosarcomas - not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation
* Received a blood or platelet transfusion during the 2 weeks prior to Cycle 1 Day 1 (C1D1). Participants' hemoglobin must be assessed within 2 weeks of screening and at least 1 week post transfusion
* Concurrent systemic steroid therapy higher than physiologic dose (\&gt; 10 milligram per day \[mg/day\] of prednisone or equivalent). Systemic steroid therapy as pre-medication for taxane is allowed
* Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:

  * Not recovered from major surgery \&lt;= 28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted
* Having ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade \&gt; 1, with the exception of alopecia. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor
* Palliative radiotherapy within 14 days of the intended C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect evidence of disease progression.
* Any gastrointestinal dysfunctions that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 \&gt; grade 1).
* Participants unable to tolerate two forms of antiemetics for at least 2 cycles will not be eligible for the trial.
* Active, ongoing or uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
* Serious psychiatric or medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
* Previous treatment with an XPO1 inhibitor.
* Stable disease or PD on the post-chemotherapy scan or clinical evidence of progression prior to randomization.
* Participants who received any systemic anticancer therapy including investigational agents \&lt;= 3 weeks (or \&lt;= 5 half-lives of the drug \[whichever is shorter\]) prior to C1D1.
* Major injuries or surgery within 14 days prior to C1D1 and/or planned major surgery during the on-treatment study period.
* Other malignant disease with disease-free \&lt;= 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor, or other agents used in the study.
* Active brain metastases (e.g., stable for \&lt; 8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
* Females who are pregnant or lactating.
* Any other life-threatening illness, active medical condition, organ system dysfunction, or serious active psychiatric issue which, in the Investigator\&#39;s opinion, could compromise the participant's safety or the participant's ability to remain compliant with study procedures.

Primary outcomes:
measure: Progression Free Survival (PFS) Assessed by Investigator as per RECIST v1.1
timeFrame: Time from randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 34 months
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of study drug administration up to 34 months
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values, Vital Signs and Physical Examination Reported as an Adverse Event
timeFrame: From start of study drug administration up to 34 months
measure: Number of Participants With Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
timeFrame: From start of study drug administration up to 34 months
measure: Time to First Subsequent Therapy (TFST)
timeFrame: Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
measure: Time to Second Subsequent Therapy (TSST)
timeFrame: Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
measure: Progression-free Survival After Consecutive Treatment (PFS2)
timeFrame: Time from randomization until the second progression event or death due to any cause, whichever occurs first (up to 34 months)
measure: Progression-free Survival (PFS) Assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1
timeFrame: Time from randomization until PD or death, whichever occurs first (up to 34 months)
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: Baseline up to 34 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Honor Health
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Irvine
country: United States
facility: Chao Family Comprehensive Cancer Center and Ambulatory Care
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Lennar
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA - Women's Health Clinical Research Unit
state: California
city: Los Angeles
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Highlands Ranch
country: United States
facility: Highlands Ranch Hospital
state: Colorado
city: Highlands Ranch
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Dyer
country: United States
facility: Northwest Cancer Center
state: Indiana
city: Goshen
country: United States
facility: Goshen Health
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Hospital
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Trials365, LLC
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: USON - Minnesota Oncology Hematology
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic's Gynecologic Oncology
state: Mississippi
city: Kansas City
country: United States
facility: Midwest Ventures Group HCA MId America Division
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Reno
country: United States
facility: Center Of Hope
state: Nevada
city: Neptune
country: United States
facility: Hackensack Meridian Health Jersey Shore University Medical Center
state: New Jersey
city: Albany
country: United States
facility: Women's Cancer Care Associates, LLC
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island
state: New York
city: New York
country: United States
facility: Mount Sinai Chelsea
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Sylvania
country: United States
facility: ProMedica Flower Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Langhorne
country: United States
facility: Alliance Cancer Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee - Women's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network - West Penn Hospital
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga's Program in Women's Oncology
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: USON - Texas Oncology, Austin Central
state: Texas
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, PC, Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/ Freodtert Hospital
state: Wisconsin
city: Albury East
country: Australia
facility: Border Medical Oncology and Haematology
state: New South Wales
city: Campbell Town
country: Australia
facility: Macarthur Cancer Therapy Centre
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Gosford
country: Australia
facility: Central Coast LHD - Gosford & Wyong Hospitals
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Newcastle Private Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: ICON Cancer Centre Southport
state: Queensland
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital - Eastern Health (Oncology)
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre/RWH/RMH
state: Victoria
city: Southport
country: Australia
facility: The Royal Adelaide Hospital
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St. Luc
city: Gent
country: Belgium
facility: AZ Sint Lucas
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Namur
country: Belgium
facility: CHU UCL Namur, Site Sainte-Elisabeth
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Brno
country: Czechia
facility: University Hospital Brno
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: UH Královské Vinohrady
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: Hospital Na Bulovce
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: Todua Clinic
city: Tbilisi
country: Georgia
facility: LTD New Hospitals
city: Tbilisi
country: Georgia
facility: Tbilisi Cancer Center
city: Tbilisi
country: Georgia
facility: JSC - K.Eristavi National Center of Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: Caucasus Medical Centre
city: Tbilisi
country: Georgia
facility: LTD Innova Medical Center
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic "Consilium Medulla"
city: Berlin
country: Germany
facility: Charite Berlin Universitatsmedizin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Kiel
country: Germany
facility: University Hospital Dresden
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
city: Liepzig
country: Germany
facility: Universitätsklinik Leipzig
city: Mainz
country: Germany
facility: Universitätsfrauenklinik Mainz
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Munich
country: Germany
facility: Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Ulm
country: Germany
facility: Universitätsfrauenklinik Ulm
city: Maroúsi
country: Greece
facility: IASO Hospital
state: Athens
city: Athens
country: Greece
facility: ALEXANDRA Hospital
city: Athens
country: Greece
facility: Hygeia Hospital
city: Thessaloníki
country: Greece
facility: Euromedica General Clinic
city: Debrecen
country: Hungary
facility: Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen
city: Győr
country: Hungary
facility: Petz Aladár University Teaching Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St. James Hospital
city: Galway
country: Ireland
facility: Galway University
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Hadera
country: Israel
facility: Hillel-Yaffe Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna
city: Brescia
country: Italy
facility: ASST Spedali Civili Di Brescia
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica
city: Milano
country: Italy
facility: Instituto Europeo di Oncologia
city: Milano
country: Italy
facility: Humanitas San Pio X Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Monza
country: Italy
facility: Ospedale San Gerardo - Asst Monza
city: Napoli
country: Italy
facility: "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pisa
country: Italy
facility: Universita di Pisa
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli - ROMA
city: Torino
country: Italy
facility: Ospedale Ostetrico Ginecologico Sant'Anna
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Changwon-si
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Cheonan-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center (NCC)
city: Seongbuk-gu
country: Korea, Republic of
facility: Severance Hospital (Yonsei University Health System)
city: Seongnam-si
country: Korea, Republic of
facility: CHA University/Bundang CHA General Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Bratislava
country: Slovakia
facility: St. Elisabeth Cancer Institute
city: Bratislava
country: Slovakia
facility: UH Bratislava
city: Bratislava
country: Slovakia
facility: National Cancer Institute
city: Trenčín
country: Slovakia
facility: UH Trenčín
city: Badalona
country: Spain
facility: ICO Badalona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia Hospitalet
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: El Palmar Murcia
country: Spain
facility: Virgen de la Arrixaca University Clinical Hospital
city: Gipuzkoa
country: Spain
facility: Hospital Universitario Donostia
city: Girona
country: Spain
facility: Institut Catala d'Oncologia de Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: H 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitatrio Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital LaFe Uacenlia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: TaiChung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Adana
country: Turkey
facility: Adana Baskent Hospital
Study officials:
References: