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

Grupo Espanol Multidisciplinario del Cancer Digestivo1,104 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,104

Conditions

Metastatic Colon Cancer

Interventions

ChemotherapyDRUG

Metastatic colon cancer, first line treatment with conventional chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Patients older than 70 years with frailty criteria.

Locations (48)

Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Hospital General Universitario de Elda

Elda, Alicante, Spain

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Outcomes

Primary Outcomes

Overall survival

From date of inclusion until the date of death from any cause.

Time frame: From July 2018 (LPI), 24 months

Secondary Outcomes

Validate prognostic score GEMCAD

The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores. GEMCAD score: patients are classified as stage 1 if LiM are considered resectable (\<4 nodules and \<5 cm diameter) or potentially resectable (\>4 and \<10 nodules or \>5 cm diameter), PS 0-1 and LDH \< 1.5 ULN; stage 2 if LiM are not resectable or with extrahepatic spread, PS 0-1 and LDH \< 1.5 ULN; stage3 if PS 2 or LDH \> 1.5 ULN. This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).

Time frame: From August 2014, up to 36 months

To compare GERCOR and Köhne classification with GEMCAD classification

Time frame: From August 2014, up to 36 months

Evaluate Sadananda cellular phenotype classification

Time frame: From August 2014, up to 36 months

Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy

Study whether there are demographic variables, analytical or related tumor and its extension to allow us to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy

Time frame: From August 2014, up to 36 months