| NCT ID | NCT06490536 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | IFOM ETS - The AIRC Institute of Molecular Oncology |
| Condition | Colon Cancer Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 700 participants in total. It began in 2024-10-22 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 available. Exclusion Criteria: History of other tumors within five years. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B/C infection. Medical conditions contraindicating treatment. Prior neoadjuvant treatment administered before surgery. Endpoints: Primary: Evaluate disease recurrence after two years. Secondary: Assess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires. The study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.
Eligibility Criteria
Inclusion Criteria: * SAGITTARIUS trial written informed consent. * Age ≥ 18 years. * Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery. * Availability of the original FFPE tumor tissue. * ECOG performance status 0-1. * Normal organ functions (as defined in section 9.3). * Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods. Exclusion Criteria: * History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage). * Current or recent treatment with another investigational drug or participation in another investigational study. * Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. * Inadequate contraception (male or female patients) if of childbearing or procreational potential. * Clinically relevant cardiovascular disease. * Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease. * Pre-existing neuropathy \> grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment. * Has a known history of Human Immunodeficiency Virus (HIV). * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus infection. * Has a known history of active TB (Bacillus Tuberculosis). * Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications. * Prior neoadjuvant treatment administered before surgery.
Contact & Investigator
Clara Montagut
PRINCIPAL INVESTIGATOR
Hospital del Mar
Frequently Asked Questions
Who can join the NCT06490536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06490536 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 700 participants.
Is NCT06490536 currently recruiting?
Yes, NCT06490536 is actively recruiting participants. Contact the research team at sagittarius@ifom.eu for enrollment information.
Where is the NCT06490536 trial being conducted?
This trial is being conducted at Berlin, Germany, Biella, Italy, Brescia, Italy, Genova, Italy and 11 additional locations.
Who is sponsoring the NCT06490536 clinical trial?
NCT06490536 is sponsored by IFOM ETS - The AIRC Institute of Molecular Oncology. The principal investigator is Clara Montagut at Hospital del Mar. The trial plans to enroll 700 participants.
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