Personalized treatment for high-risk colon cancer using liquid biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Sagittarius Trial aims to improve outcomes for high-risk stage II and stage III colon cancer patients by utilizing liquid biopsy (LB) to detect residual cancer DNA after surgery. Patients will be randomized into either standard chemotherapy or personalized treatment based on their LB results, allowing for tailored therapies that may reduce unnecessary toxicity. The study will also evaluate recurrence times, side effects, quality of life, and the accuracy of LB in monitoring treatment response. This phase 3 trial seeks to establish the efficacy of targeted therapies compared to conventional approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Clara Montagut — Hospital del Mar
• Study coordinator: Silvia Marsoni
• Email: sagittarius@ifom.eu
• Phone: +39 02.574303862

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant chemotherapy versus immediate surgery for high-risk colon cancer

  This study is testing whether giving chemotherapy before surgery can help people with high-risk colon cancer live longer and healthier compared to having surgery right away.

  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT05194878

• Neoadjuvant dostarlimab before surgery for resectable stage III pMMR/MSS colon cancer

  This will test whether two pre-surgery infusions of the PD-1 drug dostarlimab help people with resectable stage III pMMR/MSS colon cancer.

  Recruiting Phase 2 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT06830239

• Using blood tests to guide chemotherapy in stage II colon cancer patients

  This study tests if using blood tests to check for tumor DNA can help doctors decide if stage II colon cancer patients need extra chemotherapy after surgery.

  Recruiting at 29 sites UMC Utrecht · 's-Hertogenbosch and 28 other locations · NCT06434896

• mFOLFIRINOX versus mFOLFOX as additional treatment for high-risk stage III colon cancer

  This trial will test whether giving mFOLFIRINOX instead of mFOLFOX after surgery helps people with high-risk stage III colon cancer (pT4N1/2 or any pT with N2) stay cancer-free longer.

  Recruiting Phase 2/3 Chungnam National University Hospital · Daejeon · NCT05179889

• Using virtual reality to help manage pain in GI cancer patients

  This study is testing if virtual reality can help people with GI cancer manage their severe abdominal pain better than standard treatments.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT04907643

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.