Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

January 7, 2019

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Colorectal CancerChemotherapy-induced Peripheral Neuropathy
Interventions
DRUG

Calmangafodipir (5 µmol/kg)

PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials.

OTHER

Placebo

Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials.

Trial Locations (65)

Unknown

Onze-Lieve-Vrouwziekenuis Aalst, Aalst

Imelda GI Clinical Research Center, Bonheiden

Cliniques Universitaires St-Luc, Brussels

UZ Gent, Ghent

CHU Liège, Liège

AZ Sint Maarten, Mechelen

AZ Delta, Roeselare

CHU UCL Namur - Site Godinne, Yvoir

Nemocnice Benesov, Benešov

Nemocnice Horovice, Hořovice

Nemocnice Na Pleši, Nová Ves Pod Plesi

General University Hospital, Prague

Onkologická Klinika 1. Lf Uk A Tn, Prague

CHRU de Brest - Hôpital Morvan, Brest

Clinique Pasteur-Lanroze, Brest

Centre Hospitalier Départemental de Vendée - Unité de recherche clinique, La Roche-sur-Yon

Centre Oscar Lambret, Lille

Hôpital Edouard Herriot - HCL, Lyon

Hôpital Nord Franche-Comté Site du Mittan, Montbéliard

CHU Nice L'Archet 2, Nice

Clinique Ste Anne, Strasbourg

Hopitaux Universitaires de Strasbourg, Strasbourg

Hämatolgisch-onkologische Praxis Augsburg, Augsburg

Onkozentrum Dresden, Dresden

Universitätsklinikum Carl Gustav Carus, Dresden

Onkodok GmbH / Onkologische Schwerpunktpraxis, Gütersloh

Klinikum Neuperlach, München

Oncologia Istituti Ospitalieri, Cremona

Irccs Irst, Meldola - FC

Hospital San Gerardo, Monza

Istituto Nazionale Tumori, Napoli

IRCCS Policlinico San Matteo, Pavia

Ospedale degli infermi, Ponderano

IRCCS azienda Ospedaliera S Maria Nuova, Reggio Emilia

Casa Sollievo della Sofferenza, San Giovanni Rotondo

Fukuoka University Hospital, Fukuoka

Kyushu University Hospital, Fukuoka

St. Marianna University School of Medicine Hospital, Kawasaki

Aichi Cancer Center Hospital, Nagoya

National Hospital Organization Osaka National Hospital, Osaka

Osaka International Cancer Institute, Osaka

Osaka University Hospital, Osaka

Sapporo Medical University Hospital, Sapporo

Shizuoka Cancer Center, Shizuoka

The Cancer Institute Hospital of JFCR, Tokyo

Fujita Health University Hospital, Toyoake

Hallym University Sacred Heart Hospital, Anyang-si

Dong-A University Hospital, Busan

Chonnam National University Hwasun Hospital, Gwangju

Seoul National University Bundang Hospital, Seongnam-si

Korea University Guro Hospital, Seoul

Seoul National University Hospital, Seoul

Granvia de L´Hospitalet 199-203, Barcelona

Hospital de La Santa Creu I Sant Pau, Barcelona

Vall d'hebron university hospital, Barcelona

Centro Integral Oncologico, Madrid

H.G.U.Gregorio Marañón, Madrid

Hospital Universitario Puerta de Hierro, Majadahonda

Hospital Univ Virgen Macarena, Seville

Hospital Quironsalud Valencia, Valencia

KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Mid Essex Hospital Services NHS Trust - Broomfield Hospital, Chelmsford

North Tyneside General Hospital, North Shields

Mount Vernon Cancer Centr, Northwood

The Royal Marsden Hospital (Surrey), Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Solasia Pharma K.K.

INDUSTRY

lead

Egetis Therapeutics

INDUSTRY

NCT04034355 - Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer | Biotech Hunter | Biotech Hunter