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

Grupo Espanol Multidisciplinario del Cancer Digestivo

Status

Unknown

Conditions

Metastatic Colon Cancer

Treatments

Biological: Chemotherapy plus monoclonal antibody

Drug: Chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT02254941

GEMCAD 1401

Details and patient eligibility

About

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.

Enrollment

1,104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with metastatic colorectal cancer with biopsy positive for adenocarcinoma.
ECOG PS0-2.
Who have not received prior chemotherapy treatment for metastatic disease.
Measurable or evaluable disease.
No previous surgery for metastatic disease. Surgery for metastasis allowed after inclusion in the study aftercare at the discretion of investigadors.
Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)

Exclusion criteria