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Study on the Effect of Intensive Chemotherapy with FOLFOXIRI Compared to Standard Treatment for Patients with Localized Colon Cancer

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What is this trial about?

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

This clinical trial is focused on studying the effects of different chemotherapy treatments for patients with localized colon cancer at stages II and III. The study aims to compare an intensive chemotherapy treatment called FOLFOXIRI with a standard treatment known as CAPOX. FOLFOXIRI is a combination of several drugs: fluorouracil, oxaliplatin, irinotecan, and folinic acid. CAPOX combines capecitabine and oxaliplatin. The purpose of the study is to see how effective these treatments are in clearing circulating tumor DNA (ctDNA), which is a marker that can indicate the presence of cancer cells in the body.

Participants in the study will receive either the intensive FOLFOXIRI treatment or the standard CAPOX treatment. The study will monitor the effects of these treatments over a period of time to determine which is more effective in reducing ctDNA levels. The trial will also look at the overall health and quality of life of the participants during and after the treatment. The study is expected to continue until the end of 2026.

The trial will assess the proportion of patients who show no detectable ctDNA after treatment, comparing the results between the two treatment groups. Additionally, the study will evaluate the disease-free survival rates of participants, which means the length of time they remain free from cancer after treatment. The trial will also monitor any side effects experienced by participants and compare the quality of life between those receiving FOLFOXIRI and those receiving CAPOX.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of chemotherapy. Two treatment options are available: an intensive treatment called FOLFOXIRI and a standard treatment called CAPOX.

    The FOLFOXIRI regimen includes the following medications: fluorouracil, oxaliplatin, irinotecan hydrochloride trihydrate, and folinic acid. These are administered through intravenous infusion.

    The CAPOX regimen includes capecitabine taken orally and oxaliplatin administered through infusion.

  2. Step 2

    Treatment administration

    For the FOLFOXIRI regimen, fluorouracil is given as an intravenous infusion, oxaliplatin and irinotecan hydrochloride trihydrate are administered as solutions for infusion, and folinic acid is provided as a solution for injection.

    For the CAPOX regimen, capecitabine is taken in the form of film-coated tablets, and oxaliplatin is given as a solution for infusion.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the effect of the treatment on circulating tumor DNA (ctDNA) is monitored. The primary goal is to determine the proportion of patients who show no detectable ctDNA after treatment.

    Secondary evaluations include comparing disease-free survival rates between the two treatment groups at 12 and 24 months after treatment.

  4. Step 4

    Quality of life assessment

    Quality of life is assessed using specific questionnaires designed for cancer patients. These assessments occur at the start of the trial, after 3 months, and at the end of the treatment.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by December 31, 2026. Final results will include data on the effectiveness of the treatments and their impact on quality of life.

Who can join the trial?

10 criteria

  • Must provide written informed consent to participate in the CIRCULATE-SPAIN-01 trial.
  • Age must be between 18 and 75 years old.
  • Must have a confirmed diagnosis of **Colon Cancer** that is operable and at stage II or III. This means the cancer is located in the colon and has not spread to distant parts of the body.
  • Must be **ctDNA positive** after surgery. **ctDNA** stands for circulating tumor DNA, which is a type of DNA from cancer cells found in the blood.
  • Must have an **ECOG performance status** of 0-1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must have normal organ functions, which include:
    • **Absolute neutrophil count (ANC)** of at least 1500 per microliter. Neutrophils are a type of white blood cell important for fighting infections.
    • **Platelets** of at least 100,000 per microliter. Platelets help with blood clotting.
    • **Hemoglobin** of at least 9.0 grams per deciliter or 5.6 millimoles per liter. Hemoglobin is a protein in red blood cells that carries oxygen.
    • **Total bilirubin** of no more than 1.5 times the upper limit of normal (ULN), or direct bilirubin within normal limits if total bilirubin is higher. Bilirubin is a substance made during the breakdown of red blood cells.
    • **AST (SGOT)** and **ALT (SGPT)** levels no more than 2.5 times the ULN. These are enzymes that help assess liver function.

Who cannot join the trial?

5 criteria

  • Patients with medical conditions other than localized colon cancer (stage II-III) cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are not able to follow the study procedures or comply with the study requirements are not eligible.
  • Patients who have received other treatments that might interfere with the study results are excluded.
  • Individuals with any other health issues that the study doctors believe could affect the study results or the patient's safety are not allowed to participate.
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Investigated drugs

  • FOLFOXIRI

    is a combination of chemotherapy drugs used as an intensive adjuvant treatment. It is designed to help eliminate any remaining cancer cells after surgery in patients with localized colon cancer. This combination aims to clear circulating tumor DNA (ctDNA), which can be a marker of treatment effectiveness.

  • CAPOX

    is a conventional adjuvant chemotherapy regimen. It is used to treat patients with localized colon cancer by targeting and destroying cancer cells that may remain after surgery. This treatment is compared to the more intensive FOLFOXIRI regimen to evaluate differences in effectiveness.

What is already known about the treatment

  • FOLFOXIRI

    This medication is administered intravenously and is used as an intensive adjuvant chemotherapy treatment. It is currently being studied in clinical trials for its effectiveness in treating localized colon cancer, specifically stages II and III. The main therapeutic indication is to clear circulating tumor DNA, which serves as a biomarker for treatment efficacy. FOLFOXIRI works by combining several chemotherapy agents that target cancer cells at the molecular level, disrupting their growth and division. It is classified pharmacologically as a combination chemotherapy regimen.

  • CAPOX

    This medication is also administered intravenously and is used as a standard adjuvant chemotherapy treatment. It is being compared in clinical trials to FOLFOXIRI for its effectiveness in treating localized colon cancer, stages II and III. The primary therapeutic indication is to reduce the risk of cancer recurrence by targeting and destroying cancer cells. CAPOX combines chemotherapy agents that interfere with DNA synthesis and repair in cancer cells, preventing their proliferation. It is classified as a combination chemotherapy regimen.

Investigated diseases

Localized Colon Cancer (Stage II-III) – This type of cancer originates in the colon, which is part of the large intestine. In stage II, the cancer has grown through the wall of the colon but has not spread to nearby lymph nodes. By stage III, the cancer has spread to nearby lymph nodes but not to other parts of the body. The progression involves the growth of cancerous cells that can invade surrounding tissues. As the disease advances, it may cause symptoms such as changes in bowel habits, abdominal pain, and weight loss. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518131-11-02Protocol codeCIRCULATE-SPAIN-01Estimated enrolment124 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).