Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT02254941 |
Recruitment Status :
Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : July 23, 2020
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Condition or disease | Intervention/treatment |
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Metastatic Colon Cancer | Drug: Chemotherapy Biological: Chemotherapy plus monoclonal antibody |
Study Type : | Observational |
Actual Enrollment : | 1104 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer |
Actual Study Start Date : | August 2014 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Group/Cohort | Intervention/treatment |
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Active comparator: Chemotherapy
Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
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Drug: Chemotherapy
Metastatic colon cancer, first line treatment with conventional chemotherapy
Other Name: Standard Chemotherapy |
Experimental: Chemotherapy plus mAb
Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
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Biological: Chemotherapy plus monoclonal antibody
Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
Other Name: Standard CHemotherapy plus monoclonal antibody |
- Overall survival [ Time Frame: From July 2018 (LPI), 24 months ]From date of inclusion until the date of death from any cause.
- Validate prognostic score GEMCAD [ Time Frame: From August 2014, up to 36 months ]
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).
- To compare GERCOR and Köhne classification with GEMCAD classification [ Time Frame: From August 2014, up to 36 months ]
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).
- 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 [ Time Frame: From August 2014, up to 36 months ]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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254941

Study Chair: | Joan Maurel, MD PhD | Hospital Clínic de Barcelona |
Responsible Party: | Grupo Espanol Multidisciplinario del Cancer Digestivo |
ClinicalTrials.gov Identifier: | NCT02254941 |
Other Study ID Numbers: |
GEMCAD 1401 |
First Posted: | October 2, 2014 Key Record Dates |
Last Update Posted: | July 23, 2020 |
Last Verified: | July 2020 |
Metastatic Colon Cancer Monoclonal antibodies Chemotherapy First line |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Antineoplastic Agents, Immunological Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |