Clinical trial NCT05270044: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Official title: Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Melanoma
Stage II
BRAFV600E/K
Adjuvant
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2022-03-08
Enrollment: 815
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 the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

Detailed description: This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.

Participants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:

* stage IIB (i.e., pT3b or pT4a)
* stage IIC (i.e., pT4b).

The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.

Eligibility criteria: Inclusion Criteria:

Pre-Screening

* Male or female ≥ 18 years of age;
* Surgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;
* Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.
* Sentinel node (SN) staged node negative (pN0);
* Available tumour sample for central determination of the BRAF V600E/K mutation.

Screening

* Melanoma confirmed centrally to be BRAF V600E/K mutation-positive;
* Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);
* No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;
* Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);
* ECOG performance status of 0 or 1;
* Adequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin

  ≥ 9.0 g/dL;
* Adequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;
* Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;
* Adequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and \< 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;
* Adequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;
* Adequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;
* Negative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;
* Female patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration.

Exclusion Criteria:

Pre-screening

* Unknown ulceration status;
* Uveal and mucosal melanoma;
* Clinically apparent metastases (N+/M1);
* Microsatellites, satellites and/or in-transit metastases,
* Local (scar) recurrences.

Screening

* Breast feeding women;
* Pregnant women;
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
* History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization;
* History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years;
* Participants with a prior cancer associated with RAS mutation;
* Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma;
* Hypersensitivity to the study drugs or to any of the excipients;
* Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);
* Impaired cardiovascular function or clinically significant cardiovascular diseases;
* Neuromuscular disorders that are associated with CK \> ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy);
* Non-infectious pneumonitis and Interstitial Lung Disease;
* Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending;
* Active bacterial, fungal, or viral infection, including, but not limited to HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: Approximately 4.4 years from the accrual of the first patient.
Secondary outcomes:
measure: Distant metastasis-free survival (DMFS)
timeFrame: Approximately 6.0 years from first patient in
measure: Overall survival (OS)
timeFrame: Approximately 10 years from first Patient In.
measure: Safety - Incidence, nature, severity and seriousness of treatment emergent adverse events (TEAEs)
timeFrame: From the signing of the ICF up to 30 days after end of treatment- approximately 14.5 months
measure: Safety -Incidence, nature and severity of cutaneous malignancies by dermatological examination
timeFrame: From the signing of ICF to study completion- approximately 10 years from last patient in
measure: Safety -Incidence of Serious adverse events (SAEs)
timeFrame: From the signing of the ICF to study completion- approximately 10 years from last patient in
measure: Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in physical examination
timeFrame: From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months
measure: Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs
timeFrame: From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months
measure: Safety and tolerability : Incidence of TEAEs related to notable changes in clinical safety laboratory parameters from baseline.
timeFrame: From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months
measure: Safety and tolerability -Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs)
timeFrame: From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months
measure: Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of echocardiogram or multigated acquisition (ECHO/MUGA) scans.
timeFrame: From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months
measure: Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in ophtalmic examination
timeFrame: From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months
measure: Safety and tolerability-Treatment emergent adverse events (TEAEs) leading to dose interruption, reduction and discontinuation.
timeFrame: On treatment period - 12 months from randomization.
measure: Performance status using the Eastern Co-operative Oncology Group (ECOG) performance status scale.
timeFrame: From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months
measure: Patient-reported health-related (HRQoL)-European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) .
timeFrame: From the signing of the ICF up to 30 months.
measure: Patient-reported health-related (HRQoL)_European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30)
timeFrame: From the signing of the ICF up to 30 months.
measure: Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_Cmin
timeFrame: From randomization up to 11 months
measure: Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)-Cmax
timeFrame: From randomization up to 11 months
measure: Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_AUC
timeFrame: From randomization up to 11 months
measure: Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmin
timeFrame: From randomization up to 11 months
measure: Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmax
timeFrame: From randomization up to 11 months
measure: Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-AUC
timeFrame: From randomization up to 11 months
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Centro Oncologico Korben
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Ciudad Autonoma Bs As
country: Argentina
facility: Fundacion CIDEA
state: Ciudad Autonoma Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio Britanico S.A.
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
state: Santa Fe
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: North Adelaide
country: Australia
facility: Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Graz
country: Austria
facility: Landeskrankenhaus - Universitaetsklinikum Graz
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
city: St. Pölten
country: Austria
facility: Universitätsklinikum St.Pölten-Lilienfeld
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Merksem
country: Belgium
facility: ZNA
city: Sint-Niklaas
country: Belgium
facility: Vitaz
city: Yvoir
country: Belgium
facility: CHU UCL Namur
city: Salvador
country: Brazil
facility: AMO - Assistência Multidisciplinar em Oncologia
state: Bahia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
state: Paraná
city: Londrina
country: Brazil
facility: Instituto de Cancer de Londrina
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center
state: Rio Grande Do Sul
city: Santa Cruz Do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
state: Santa Catarina
city: Jaú
country: Brazil
facility: Fundação Doutor Amaral Carvalho
state: Sao Paulo
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: Sao Paulo
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
state: Sao Paulo
city: London
country: Canada
facility: London Health Sciences Centre (LHSC) - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: CIUSSS du Centre Ouest de l'lle de Montreal
state: Quebec
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Nice cedex 3
country: France
facility: CHU Nice - Hopital de l Archet 2
state: Alpes Maritimes
city: Marseille cedex 5
country: France
facility: Hôpital de la Timone
state: Bouches-du-Rhône
city: Dijon
country: France
facility: CHU de Dijon - Hôpital du Bocage
state: Cote dÝOr
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint André
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud - Oncopole
state: Haute Garonne
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
state: Hauts De Seine
city: Rennes cedex
country: France
facility: CRLCC Eugene Marquis
state: Ille Et Vilaine
city: Chambray-lès-Tours
country: France
facility: CHU Tours - Hôpital Trousseau
state: Indre Et Loire
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital André Michallon
state: Isere
city: Nantes Cedex 1
country: France
facility: CHU Nantes - Hôtel Dieu
state: Loire Atlantique
city: Saint Etienne Cedex 2
country: France
facility: CHU Saint Etienne - Hôpital Nord
state: Loire
city: Lille cedex
country: France
facility: Hopital Claude Huriez - CHU Lille
state: Nord
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis
state: Paris
city: Clermont-Ferrand
country: France
facility: CAC Clermont-Ferrand Centre Jean Perrin
state: Puy De Dome
city: Pau cedex
country: France
facility: Centre Hospitalier de Pau - Hôpital François Mitterrand
state: Pyrenees Atlantiques
city: Pierre Bénite cedex
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
state: Seine Maritime
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital la Milétrie
state: Vienne
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
state: Bayern
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude GmbH
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
state: Schleswig Holstein
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Néo Fáliro
country: Greece
facility: Metropolitan Hospital
city: Thessaloníki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloníki
country: Greece
facility: Anticancer Hospital of Thessaloniki " Theagenio"
city: Thessaloníki
country: Greece
facility: Interbalkan Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Győr
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Meldola
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
state: Forli - Cesena
city: Taormina
country: Italy
facility: Ospedale San Vincenzo
state: Messina
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Napoli
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico
state: Pordenone
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera S.Croce e Carle
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
city: Roma
country: Italy
facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS
city: Sassari
country: Italy
facility: Policlinico Universitario di Sassari
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG)
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed
city: Kraków
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Skórzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
city: Wrocław
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Cluj-Napoca
country: Romania
facility: S.C Medisprof S.R.L
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Belgrade
country: Serbia
facility: Clinical Center "Bezanijska kosa"
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niš
country: Serbia
facility: Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Bloemfontein
country: South Africa
facility: National Hospital Oncology
state: Free State
city: Centurion
country: South Africa
facility: Johese Clinical Research: Midstream
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group
state: Gauteng
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
state: Tyne & Wear
Study officials:
affiliation: European Organisation for Research and Treatment of Cancer - EORTC
name: Alexander C.J. van AKKOOI, MD, PhD
role: STUDY_CHAIR
References: