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TINzaparin Prophylaxis in Patients With Metastatic Colorectal Cancer

NCT05625932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2025-08-22

No results posted yet for this study

Summary

Patients with metastatic colorectal cancer (mCRC) who are scheduled to receive systemic cancer therapy have an increased risk for venous thromboembolic (VTE) events compared with the general population.

PROTINCOL is a randomized, open label, non placebo-controlled, low intervention, and phase III clinical trial that will recruit patients with mCRC. The study hypothesizes that prophylaxis with Tinzaparin could prevent the appearance of symptomatic and incidental VTE.

All patients will receive the first-line anticancer treatment deemed more appropriate according to the physician criteria. Enrolled patients are randomized in a 1:1 ratio (stratifying by BRAF/RAS, resection of primary tumor, and anti-angiogenic first-line treatment) to: control arm (no interventions related to VTE risk and no placebo) or experimental arm (prophylactic Tinzaparin at a fixed dose of 4500 IU/day in patients with up to 80kg, 6000 IU/day for those between 80-100 kg, or 8000 IU/day for those \>100kg). Treatment is scheduled for a maximum period of 4 months. Treatment could be stopped earlier in case of unacceptable toxicity, patient consent withdrawal, physician criteria or end of study. Patients will undergo tumor and VTE assessments according to standard clinical practice.

The main objective of the study is to evaluate the efficacy of tinzaparin for the prevention of symptomatic or incidental VTE events. Secondary objectives include the associations between VTE events and tumor characteristics (i.e. laterality, RAS/BRAF mutations) or management (i.e. surgery or treatment with anti-angiogenic or anti-EGFR agents), cancer-specific survival outcomes, safety, the incidence of bleeding events, and patient-reported quality of life. The trial includes also a translational exploratory analysis to assess the predictive value of risk assessment models and genetic risk scores, their evolution through the study and microsatellite instability or other biomarkers.

Conditions

  • Colorectal Cancer Metastatic
  • Thromboembolism

Interventions

DRUG

Tinzaparin

Patients \< 80 kg will receive a fixed dose of 4500 IU daily. Patients between 80-100 kg will receive a fixed dose of 6000 IU daily. Patients \> 100 kg will receive a fixed dose of 8000 IU daily.

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY

  • Galician Research Group on Digestive Tumors

    lead OTHER

Principal Investigators

  • Mercedes Salgado, M.D. Ph.D. · Complexo Hospitalario Universitario de Ourense (Galicia)

  • Andrés Muñoz, M.D. Ph.D. · Hospital Universitario Gregorio Marañón (Madrid)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-02
Primary Completion
2025-06-04
Completion
2025-06-04

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05625932 on ClinicalTrials.gov