The Sagittarius Trial

Recruiting now · Phase 3

Conditions studied: Colon Cancer Stage II, Colon Cancer Stage III

In brief

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.

Key facts

Study ID

NCT06490536

Run by

IFOM ETS - The AIRC Institute of Molecular Oncology

People needed

700

Starts

2024-10-22

Expected to finish

2028-09-01

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Azienda Sanitaria Locale di Biella — Biella, Biella, Italy (enrolling)
• Fondazione Poliambulanza — Brescia, Brescia, Italy (enrolling)
• Azienda Ospedaliera Universitaria San Martino — Genova, Genova, Italy (enrolling)
• Istituto Europeo di Oncologia — Milan, Milano, Italy (enrolling)
• Istituto Clinico Humanitas — Rozzano, Milano, Italy (enrolling)
• Ospedale Niguarda — Milan, Milan, Italy (enrolling)
• Ospedale Maggiore di Novara — Novara, Novara, Italy (enrolling)
• Azienda Ospedaliera Universitaria di Parma — Parma, Parma, Italy (enrolling)
• Ospedale Santa Maria della Misericordia — Perugia, Perugia, Italy (enrolling)
• Azienda Unità Sanitaria Locale della Romagna — Ravenna, Ravenna, Italy (enrolling)
• Policlinico Universitario Gemelli — Roma, Roma, Italy (enrolling)
• Istituto di Candiolo — Candiolo, Torino, Italy (enrolling)
• Hospital del Mar — Barcelona, Barcelona, Spain (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona, Spain (enrolling)
• INCLIVA Instituto de Investigación Sanitaria — Valencia, Spain, Spain (enrolling)
• Hospital Sant Pau Barcelona — Barcelona, Spain (enrolling)
• Consorci Corporació Sanitària Parc Taulí — Barcelona, Spain (enrolling)
• Instituto Catalán de Oncologia — Barcelona, Spain (enrolling)
• Hospital Universitario Reina Sofia — Córdoba, Spain (enrolling)
• Hospital Clinico Universitario San Carlos — Madrid, Spain (enrolling)
• Complejo Hospitalario de Navarra — Pamplona, Spain (enrolling)
• Hospital Universitario Marqués de Valdecilla — Santander, Spain (enrolling)
• Hospital Clínico Universitario de Santiago — Santiago de Compostela, Spain (enrolling)
• Hospital General Universitario de Valencia — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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