Clinical trial · Observational
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Chemotherapy plus monoclonal antibody | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Active comparator: Chemotherapy
- description
- Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
- interventionNames
- Drug: Chemotherapy
- label
- Experimental: Chemotherapy plus mAb
- description
- Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
- interventionNames
- Biological: Chemotherapy plus monoclonal antibody
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From July 2018 (LPI), 24 months
- description
- From date of inclusion until the date of death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available