The Sagittarius Trial

Launched by IFOM ETS - THE AIRC INSTITUTE OF MOLECULAR ONCOLOGY · Jun 28, 2024

Keywords

ClinConnect Summary

The Sagittarius Trial is a research study aimed at improving treatments for patients with stage II high-risk and stage III colon cancer. The trial is testing whether a personalized treatment approach, which uses genetic information from a patient's tumor and a simple blood test to detect cancer DNA, can lead to better outcomes and quality of life compared to standard chemotherapy. The study will involve about 700 patients across several hospitals in Italy, Spain, and Germany, and will last for five years.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of operable stage III or high-risk stage II colon cancer. You should also have a tumor tissue sample available. If you join the trial, you may receive either standard chemotherapy or a customized treatment based on your tumor's specific genetics. Researchers will monitor how well the treatments work and their side effects over time, and they will also check how these treatments affect your overall quality of life. If you're considering participating, it's important to discuss any other medical conditions or treatments with your healthcare provider, as there are some exclusions for certain health issues.

Gender

ALL

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.
• • Had an incomplete diagnostic colonoscopy.
• • Recent polyps' removal (within one month).
• • 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 DPD (DihydroPyrimidine Dehydrogenase) deficiency.
• • Has a known Gilbert Syndrome or UGT1A1 homozygous \*28/\*28 germline variant.
• • 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.