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Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.
The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples.
Details
| Lead sponsor | Centro Nacional de Investigaciones Oncologicas CARLOS III |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 29 |
| Start date | 2012-11 |
| Completion | 2014-12 |
Conditions
- Adenocarcinoma of Colon
- Adenocarcinoma of Rectum
- Metastatic Disease
Interventions
- Arm A chemotherapy
- arm B chemotherapy
Primary outcomes
- Overall survival — 12 months
To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference - gene expression profiles — 12 months
Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.
Countries
Spain