Condition: Colon Cancer Stage II · Colon Cancer Stage III · Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology
Background \& Rationale: Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response. Primary Objective: Show that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy. Secondary Objectives: Compare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy. Study Design: Patients are randomized into standard or personalized treatment groups based on LB results. For positive LB results: Randomized to standard or customized therapy. Monitor treatment response with LB. For negative LB results: Randomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears. Treatments: Standard Chemotherapy: CAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin) Personalized Treatments: Customized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab). Population: 700 patients with operable stage III and high-risk stage II colon cancer. Inclusion Criteria: Aged 18 or older. Confirmed diagnosis. Tumor tissue sample av…
This description comes directly from the study's public registry record.
Silvia Marsoni · +39 02.574303862 · sagittarius@ifom.eu
Always discuss trial participation with your own doctor first.
| Charité - Universitätsmedizin Berlin | Berlin, Germany | Recruiting |
| Azienda Sanitaria Locale di Biella | Biella, Biella, Italy | Recruiting |
| Fondazione Poliambulanza | Brescia, Brescia, Italy | Recruiting |
| Azienda Ospedaliera Universitaria San Martino | Genova, Genova, Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan, Milano, Italy | Recruiting |
| Istituto Clinico Humanitas | Rozzano, Milano, Italy | Recruiting |
| Ospedale Niguarda | Milan, Milan, Italy | Recruiting |
| Ospedale Maggiore di Novara | Novara, Novara, Italy | Recruiting |
| Azienda Ospedaliera Universitaria di Parma | Parma, Parma, Italy | Recruiting |
| Ospedale Santa Maria della Misericordia | Perugia, Perugia, Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna, Ravenna, Italy | Recruiting |
| Policlinico Universitario Gemelli | Roma, Roma, Italy | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06490536