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

Metastatic Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02254941
• Other study ID #: GEMCAD 1401
• Status: Active, not recruiting
• Start date: August 2014
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1104
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Metastatic Colon Cancer

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Oncologico de Galicia	A Coruña	La Coruña
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	Hospital Infanta Cristina de Badajoz	Badajoz
Spain	Centre Mèdic Teknon	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Plató	Barcelona
Spain	Hospital Universitari Sagrat Cor	Barcelona
Spain	Hosptial de l'Esperit Sant de Barcelona	Barcelona
Spain	Hospital San Pedro de Alcantara Cáceres	Cáceres
Spain	Consorcio Hospitalario Provincial de Castellón	Castelló
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
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 Univeritari Dr. Josep Trueta	Girona
Spain	Hospital Granollers	Granollers	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Arnau de Vilanova de Lleida	Lleida
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Althaia	Manresa
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Morales Meseguer	Murcia
Spain	Complejo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Son Espases	Palma	Malllorca
Spain	Hospital Universitari Son Llàtzer	Palma de mallorca
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen del Puerto de Plasencia	Plasencia	Cáceres
Spain	Hospital Provincial de Pontevedra	Pontevedra
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital de Sagunto	Sagunto
Spain	Hospital de Donostia	San Sebastián	Guipúzcoa
Spain	Hospital General de Catalunya	Sant Cugat del Vallès	Barcelona
Spain	Hospital de Terrasa	Terrassa	Barcelona
Spain	Hospital Obispo Polanco	Teruel	Zaragoza
Spain	Hospital Universitario de Torrevieja	Torrevieja	Alicante
Spain	Hospital Doctor Peset	Valencia
Spain	Hospital Universitario y Politécnico de La Fe	Valencia
Spain	Instituto Valenciano de Oncologia	Valencia
Spain	Hospital General de Vic	Vic	Barcelona
Spain	Complejo Hospitalario Universitario de Vigo	Vigo
Spain	Hospital Lluis Alcanyis de Xátiva	Xàtiva	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza	Aragon
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol Multidisciplinario del Cancer Digestivo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From date of inclusion until the date of death from any cause.	From July 2018 (LPI), 24 months
Secondary	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).	From August 2014, up to 36 months
Secondary	To compare GERCOR and Köhne classification with GEMCAD classification	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.; 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).	From August 2014, up to 36 months
Secondary	Evaluate Sadananda cellular phenotype classification		From August 2014, up to 36 months
Secondary	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	From August 2014, up to 36 months