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Study on Colon Cancer Treatment Using Disodium Levofolinate and Drug Combination for Patients with Operable Stage III and High-Risk Stage II Colon Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying treatments for colon cancer, specifically in patients with operable Stage III and high-risk Stage II colon cancer. The trial aims to explore a personalized treatment approach based on blood and tumor characteristics to guide the post-surgical clinical path of these patients. The study will use a variety of medications, including Disodium Levofolinate, Temozolomide, Irinotecan, Trastuzumab, Panitumumab, Capecitabine, Calcium Levofolinate, Folinic Acid, Oxaliplatin, Fluorouracil, Pertuzumab, Ipilimumab, and Nivolumab. These medications are administered in various forms, such as injections, infusions, and oral capsules.

The purpose of the study is to determine if a personalized treatment strategy, guided by a blood test called ctDNA (circulating tumor DNA), can improve outcomes for patients compared to the standard chemotherapy approach. The study will involve randomizing patients into different treatment groups based on their ctDNA results after surgery. Some patients will receive conventional chemotherapy, while others will receive a personalized treatment plan. The study will also include a group receiving a placebo to compare the effectiveness of the treatments.

Participants in the trial will undergo treatment for a maximum period of six months. The study will monitor the patients' health and response to the treatments over time, with follow-ups to assess the long-term effects. The trial aims to provide valuable insights into the potential benefits of personalized treatment strategies for colon cancer patients, ultimately aiming to improve their quality of life and survival rates.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of colon cancer, and overall health status.

    A written informed consent is required to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information and confirm the availability of original tumor tissue for analysis.

  3. Step 3

    Surgery

    Surgery is performed to remove the tumor. The location of the tumor is confirmed to be at least 12 cm from the anal verge.

  4. Step 4

    Post-surgery evaluation

    After surgery, a blood test is conducted to check for circulating tumor DNA (ctDNA) to determine the next steps in treatment.

  5. Step 5

    Treatment assignment

    Based on ctDNA results, patients are randomly assigned to receive either conventional chemotherapy or a personalized treatment strategy.

    Conventional chemotherapy may include drugs such as disodium levofolinate, temozolomide, irinotecan, trastuzumab, panitumumab, capecitabine, calcium levofolinate, pertuzumab, ipilimumab, folinic acid, oxaliplatin, fluorouracil, and nivolumab.

  6. Step 6

    Treatment administration

    Medications are administered either orally or through intravenous infusion, depending on the specific drug and treatment plan.

    The frequency and duration of administration vary based on the treatment strategy assigned.

  7. Step 7

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor health status and treatment effectiveness.

    Additional blood tests may be conducted to assess ctDNA levels and adjust treatment as necessary.

  8. Step 8

    End of trial

    The trial is expected to conclude by September 2028, with ongoing assessments of health outcomes and treatment effectiveness.

Who can join the trial?

7 criteria

  • Sign the SAGITTARIUS trial written informed consent, which is a document that explains the study and confirms your agreement to participate.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of operable stage III or High-Risk stage II colon cancer. This means the cancer is in a stage that can be treated with surgery and is located at least 12 cm from the anal verge (the end of the rectum) and above the peritoneal reflection (a part of the abdominal lining) during surgery.
  • Provide the original FFPE tumor tissue, which is a sample of the tumor preserved in a special way for testing.
  • Have an ECOG performance status of 0-1. This is a scale that measures your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Have normal organ functions, as defined in the study protocol.
  • If you are a woman who can have children, you must complete a pregnancy test and agree to use highly effective birth control methods.
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Investigated drugs

  • ctDNA-guided genomic-based targeted treatment

    is a personalized therapy that uses information from a patient's blood to identify specific genetic changes in their tumor. This approach helps doctors choose the most effective treatment for each individual, aiming to improve outcomes for patients with certain types of colon cancer.

  • Conventional adjuvant chemotherapy

    is a standard treatment given after surgery to help prevent cancer from returning. It involves using drugs that kill cancer cells or stop them from growing. This therapy is typically used for patients with colon cancer to reduce the risk of cancer recurrence.

What is already known about the treatment

Precision Medicine Treatment – This treatment is administered based on blood-based tumor genomics, specifically targeting colon cancer in patients with operable Stage III and high-risk Stage II. Currently, it is under clinical trial to evaluate its effectiveness compared to traditional chemotherapy. The main therapeutic indication is to improve outcomes in colon cancer patients by using a personalized approach. The mechanism of action involves analyzing circulating tumor DNA (ctDNA) to guide targeted therapy, aiming to optimize treatment based on individual genetic profiles. It falls under the pharmacological classification of targeted cancer therapies, focusing on precision medicine.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is part of the digestive system. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms often include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509851-15-00Protocol codeIFOM-CPT0092022PO008Estimated enrolment740 patientsSponsorIfom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

sourced from the EU Clinical Trials Register and site verification

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