Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design

Background: Colorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide. CRC leads to increased activation of the clotting system. Since CRC patients present a higher rate of bleeding, careful evaluation of the risk/benefits of anticoagulant prophylaxis is necessary. Aims: To evalu...

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Autores: Salgado, Mercedes, de la Camara-Gómez, Juan, García-Escobar, Ignacio, Álvarez-Llosa, Renata-Carola, González-Villarroel, Paula, Garay, David Fernández, Pàmpols-Felip, Montse, Guillot-Morales, Monica, Pelegrín-Mateo, Francisco José, Jimenez-Orozco, Encarnación, Sastre, Javier, de Castro, Eva Martínez, Coma, Eva, Bouzas, Lorena París, Ferrer-Pérez, Ana Isabel, Mompradé-Olivé, Elisabet, Cousillas-Castiñeiras, Antia, Covela-Rúa, Marta, Rojas, Mariam, Querol, Rosa, Díaz, Luis Robles, Merino, Marta, Gil, Mireia, Sánchez-Cánovas, Manuel, Elías, Teresa, Marrupe-González, David, Sánchez-Gil, Belén, Carmona-Campos, Marta, García-Ferrón, María, Soria, José Manuel, Muñoz, Andrés
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/26371
Acceso en línea:https://hdl.handle.net/20.500.13003/26371
Access Level:acceso abierto
Palabra clave:Colorectal Neoplasms
Genetics
Neoplasm Metastasis
Risk Factors
Venous Thromboembolism
Neoplasias Colorrectales
Genética
Metástasis de la Neoplasia
Factores de Riesgo
Tromboembolia Venosa
Colorectal cancer
Metastatic
Risk factors
Thromboprophylaxis
Venous thromboembolism
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spelling Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial designSalgado, Mercedesde la Camara-Gómez, JuanGarcía-Escobar, IgnacioÁlvarez-Llosa, Renata-CarolaGonzález-Villarroel, PaulaGaray, David FernándezPàmpols-Felip, MontseGuillot-Morales, MonicaPelegrín-Mateo, Francisco JoséJimenez-Orozco, EncarnaciónSastre, Javierde Castro, Eva MartínezComa, EvaBouzas, Lorena ParísFerrer-Pérez, Ana IsabelMompradé-Olivé, ElisabetCousillas-Castiñeiras, AntiaCovela-Rúa, MartaRojas, MariamQuerol, RosaDíaz, Luis RoblesMerino, MartaGil, MireiaSánchez-Cánovas, ManuelElías, TeresaMarrupe-González, DavidSánchez-Gil, BelénCarmona-Campos, MartaGarcía-Ferrón, MaríaSoria, José ManuelMuñoz, AndrésColorectal NeoplasmsGeneticsNeoplasm MetastasisRisk FactorsVenous ThromboembolismNeoplasias ColorrectalesGenéticaMetástasis de la NeoplasiaFactores de RiesgoTromboembolia VenosaColorectal cancerGeneticsMetastaticRisk factorsThromboprophylaxisVenous thromboembolismBackground: Colorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide. CRC leads to increased activation of the clotting system. Since CRC patients present a higher rate of bleeding, careful evaluation of the risk/benefits of anticoagulant prophylaxis is necessary. Aims: To evaluate low molecular weight heparin (LMWH) for primary thromboprophylaxis in metastatic CRC outpatients receiving first-line systemic cancer therapy. Methods: PROTINCOL (NCT05625932) is a randomized, open-label (PROBE), multicenter study. Patients will receive tinzaparin (75 IU/kg) or no pharmacological prophylaxis for 4 months and will be stratified based on: BRAF/RAS mutation, primary resection tumor and antiangiogenic therapy. The study outcomes will be assessed by a blinded central independent adjudication committee. The primary efficacy endpoints will include the cumulative incidence of any venous thromboembolism (VTE) event (symptomatic or incidental) including symptomatic central venous catheter VTE. Secondary variables will be clinically relevant bleedings, health-related quality of life and the predictive value of validated risk assessment scales of VTE, including the genetic risk score (TIC-ONCO). Our hypothesis is that prophylactic LMWH will reduce the 55% relative risk to an estimated VTE incidence of 13.5%. A total of 526 patients will be required. Discussion: Risk prediction of chemotherapy-associated VTE is a compelling challenge in oncology, as VTE may result in treatment delays, impaired quality of life, and increased mortality. Patients with a single type of metastatic cancer with a high risk of VTE will be selected for study inclusion. For the first time in ambulatory prophylaxis of cancer-associated thrombosis, a precision medicine approach will be used in a clinical trial. If the individualization of antithrombotic prophylaxis can reduce the complications of outpatient cancer treatment and be cost effective, it would be of great value in the future care of patients with metastatic CRC. Trial registration: NCT05625932. Registered on 15 Nov 2022. Trial status: The trial started recruitment on March 2023.Springer20252025-11-1720252025-11-17research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/26371reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/263712026-06-22T12:44:07Z
dc.title.none.fl_str_mv Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
title Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
spellingShingle Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
Salgado, Mercedes
Colorectal Neoplasms
Genetics
Neoplasm Metastasis
Risk Factors
Venous Thromboembolism
Neoplasias Colorrectales
Genética
Metástasis de la Neoplasia
Factores de Riesgo
Tromboembolia Venosa
Colorectal cancer
Genetics
Metastatic
Risk factors
Thromboprophylaxis
Venous thromboembolism
title_short Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
title_full Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
title_fullStr Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
title_full_unstemmed Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
title_sort Tinzaparin for the prevention of thromboembolic events in ambulatory patients with metastatic colorectal cancer receiving first line treatment: a randomised, clinical trial design
dc.creator.none.fl_str_mv Salgado, Mercedes
de la Camara-Gómez, Juan
García-Escobar, Ignacio
Álvarez-Llosa, Renata-Carola
González-Villarroel, Paula
Garay, David Fernández
Pàmpols-Felip, Montse
Guillot-Morales, Monica
Pelegrín-Mateo, Francisco José
Jimenez-Orozco, Encarnación
Sastre, Javier
de Castro, Eva Martínez
Coma, Eva
Bouzas, Lorena París
Ferrer-Pérez, Ana Isabel
Mompradé-Olivé, Elisabet
Cousillas-Castiñeiras, Antia
Covela-Rúa, Marta
Rojas, Mariam
Querol, Rosa
Díaz, Luis Robles
Merino, Marta
Gil, Mireia
Sánchez-Cánovas, Manuel
Elías, Teresa
Marrupe-González, David
Sánchez-Gil, Belén
Carmona-Campos, Marta
García-Ferrón, María
Soria, José Manuel
Muñoz, Andrés
author Salgado, Mercedes
author_facet Salgado, Mercedes
de la Camara-Gómez, Juan
García-Escobar, Ignacio
Álvarez-Llosa, Renata-Carola
González-Villarroel, Paula
Garay, David Fernández
Pàmpols-Felip, Montse
Guillot-Morales, Monica
Pelegrín-Mateo, Francisco José
Jimenez-Orozco, Encarnación
Sastre, Javier
de Castro, Eva Martínez
Coma, Eva
Bouzas, Lorena París
Ferrer-Pérez, Ana Isabel
Mompradé-Olivé, Elisabet
Cousillas-Castiñeiras, Antia
Covela-Rúa, Marta
Rojas, Mariam
Querol, Rosa
Díaz, Luis Robles
Merino, Marta
Gil, Mireia
Sánchez-Cánovas, Manuel
Elías, Teresa
Marrupe-González, David
Sánchez-Gil, Belén
Carmona-Campos, Marta
García-Ferrón, María
Soria, José Manuel
Muñoz, Andrés
author_role author
author2 de la Camara-Gómez, Juan
García-Escobar, Ignacio
Álvarez-Llosa, Renata-Carola
González-Villarroel, Paula
Garay, David Fernández
Pàmpols-Felip, Montse
Guillot-Morales, Monica
Pelegrín-Mateo, Francisco José
Jimenez-Orozco, Encarnación
Sastre, Javier
de Castro, Eva Martínez
Coma, Eva
Bouzas, Lorena París
Ferrer-Pérez, Ana Isabel
Mompradé-Olivé, Elisabet
Cousillas-Castiñeiras, Antia
Covela-Rúa, Marta
Rojas, Mariam
Querol, Rosa
Díaz, Luis Robles
Merino, Marta
Gil, Mireia
Sánchez-Cánovas, Manuel
Elías, Teresa
Marrupe-González, David
Sánchez-Gil, Belén
Carmona-Campos, Marta
García-Ferrón, María
Soria, José Manuel
Muñoz, Andrés
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Colorectal Neoplasms
Genetics
Neoplasm Metastasis
Risk Factors
Venous Thromboembolism
Neoplasias Colorrectales
Genética
Metástasis de la Neoplasia
Factores de Riesgo
Tromboembolia Venosa
Colorectal cancer
Genetics
Metastatic
Risk factors
Thromboprophylaxis
Venous thromboembolism
topic Colorectal Neoplasms
Genetics
Neoplasm Metastasis
Risk Factors
Venous Thromboembolism
Neoplasias Colorrectales
Genética
Metástasis de la Neoplasia
Factores de Riesgo
Tromboembolia Venosa
Colorectal cancer
Genetics
Metastatic
Risk factors
Thromboprophylaxis
Venous thromboembolism
description Background: Colorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide. CRC leads to increased activation of the clotting system. Since CRC patients present a higher rate of bleeding, careful evaluation of the risk/benefits of anticoagulant prophylaxis is necessary. Aims: To evaluate low molecular weight heparin (LMWH) for primary thromboprophylaxis in metastatic CRC outpatients receiving first-line systemic cancer therapy. Methods: PROTINCOL (NCT05625932) is a randomized, open-label (PROBE), multicenter study. Patients will receive tinzaparin (75 IU/kg) or no pharmacological prophylaxis for 4 months and will be stratified based on: BRAF/RAS mutation, primary resection tumor and antiangiogenic therapy. The study outcomes will be assessed by a blinded central independent adjudication committee. The primary efficacy endpoints will include the cumulative incidence of any venous thromboembolism (VTE) event (symptomatic or incidental) including symptomatic central venous catheter VTE. Secondary variables will be clinically relevant bleedings, health-related quality of life and the predictive value of validated risk assessment scales of VTE, including the genetic risk score (TIC-ONCO). Our hypothesis is that prophylactic LMWH will reduce the 55% relative risk to an estimated VTE incidence of 13.5%. A total of 526 patients will be required. Discussion: Risk prediction of chemotherapy-associated VTE is a compelling challenge in oncology, as VTE may result in treatment delays, impaired quality of life, and increased mortality. Patients with a single type of metastatic cancer with a high risk of VTE will be selected for study inclusion. For the first time in ambulatory prophylaxis of cancer-associated thrombosis, a precision medicine approach will be used in a clinical trial. If the individualization of antithrombotic prophylaxis can reduce the complications of outpatient cancer treatment and be cost effective, it would be of great value in the future care of patients with metastatic CRC. Trial registration: NCT05625932. Registered on 15 Nov 2022. Trial status: The trial started recruitment on March 2023.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-11-17
2025
2025-11-17
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.13003/26371
url https://hdl.handle.net/20.500.13003/26371
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Springer
publisher.none.fl_str_mv Springer
dc.source.none.fl_str_mv reponame:Docusalut
instname:Conselleria de Salut i Consum del Govern de les Illes Balears
instname_str Conselleria de Salut i Consum del Govern de les Illes Balears
reponame_str Docusalut
collection Docusalut
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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