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Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer

NCT02254941 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1104

Last updated 2022-03-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate, in terms of overall survival, the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone. Initially expected target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients, because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90% and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104 patients enrolled.

Conditions

Interventions

DRUG

Chemotherapy

Metastatic colon cancer, first line treatment with conventional chemotherapy

BIOLOGICAL

Chemotherapy plus monoclonal antibody

Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody

Sponsors & Collaborators

  • Grupo Espanol Multidisciplinario del Cancer Digestivo

    lead OTHER

Principal Investigators

  • Joan Maurel, MD PhD · Hospital Clinic of Barcelona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT02254941 on ClinicalTrials.gov