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Metastatic Colon CancerNCT02254941

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

An observational study of Metastatic Colon Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 48 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colon Cancer
What is being tested?
Chemotherapy and Chemotherapy plus monoclonal antibody
How many people
1,104 participants
Where
48 sitesSpain
Study dates
Aug 2014to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Metastatic colorectal cancer. Adenocarcinoma. First line treatment

Who may be able to join

  • 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)

Who cannot join

  • Patients older than 70 years with frailty criteria.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Spain48 sites

  • Centro Oncologico de Galicia

    A Coruña, La Coruña, 15009

  • Hospital Virgen de los Lirios

    Alcoy, Alicante

  • Hospital Infanta Cristina de Badajoz

    Badajoz

  • Centre Mèdic Teknon

    Barcelona, 08022

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hosptial de l'Esperit Sant de Barcelona

    Barcelona, 08923

  • Hospital Clinic i Provincial

    Barcelona

  • Hospital Plató

    Barcelona

  • Hospital Universitari Sagrat Cor

    Barcelona

  • Hospital San Pedro de Alcantara Cáceres

    Cáceres, 10003

  • Consorcio Hospitalario Provincial de Castellón

    Castelló, 12002

  • Hospital General de Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario del Vinalopó

    Elche, Alicante

  • Hospital General Universitario de Elda

    Elda, Alicante

  • Hospital Univeritari Dr. Josep Trueta

    Girona

  • Hospital Granollers

    Granollers, Barcelona

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Althaia

    Manresa

  • Hospital Costa del Sol

    Marbella, Málaga

  • Hospital Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Son Espases

    Palma, Malllorca

  • Hospital Universitari Son Llàtzer

    Palma de Mallorca, 08198

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Puerto de Plasencia

    Plasencia, Cáceres, 10600

  • Hospital Provincial de Pontevedra

    Pontevedra, 36002

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona

  • Hospital de Sagunto

    Sagunto

  • Hospital de Donostia

    San Sebastián, Guipúzcoa, 20014

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital de Terrasa

    Terrassa, Barcelona

  • Hospital Obispo Polanco

    Teruel, Zaragoza

  • Hospital Universitario de Torrevieja

    Torrevieja, Alicante

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Doctor Peset

    Valencia, 46017

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026

  • Hospital General de Vic

    Vic, Barcelona

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36036

  • Hospital Lluis Alcanyis de Xátiva

    Xàtiva, Valencia

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

About this study

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.

Being tested
Chemotherapy, Chemotherapy plus monoclonal antibody
Keywords
Metastatic Colon Cancer, Monoclonal antibodies, Chemotherapy, First line
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Standard Chemotherapy

    Metastatic colon cancer, first line treatment with conventional chemotherapy

  • Chemotherapy plus monoclonal antibodyBiological

    Also called Standard CHemotherapy plus monoclonal antibody

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

Study groups in NCT02254941
Study groupRoleWhat they receive
Active comparator: ChemotherapyMetastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
Receives: Drug: Chemotherapy
Experimental: Chemotherapy plus mAbMetastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
Receives: Biological: Chemotherapy plus monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: From July 2018 (LPI), 24 months

Secondary outcomes (4)

  1. 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).

    Measured: From August 2014, up to 36 months

  2. 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).

    Measured: From August 2014, up to 36 months

  3. Evaluate Sadananda cellular phenotype classification

    Measured: From August 2014, up to 36 months

  4. 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

    Measured: From August 2014, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254941
Sponsor's protocol ID
GEMCAD 1401
Status last verified
Mar 2022
First submitted
23 Sep 2014
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Colon Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 48 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From July 2018 (LPI), 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

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