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Study of chemotherapy drug combination with or without heated chemotherapy in the abdomen for patients with advanced colon cancer

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What is this trial about?

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

This study involves patients with locally advanced adenocarcinoma of the colon and upper rectum, which is a type of cancer that has grown into deeper layers of the bowel wall or nearby tissues but has not spread to distant parts of the body. The study will use several cancer-fighting medications including oxaliplatin, fluorouracil, folinic acid, capecitabine, and mitomycin. These medications work together to destroy cancer cells and are given in different combinations depending on which treatment group a patient is assigned to. Some patients will receive a treatment called hyperthermic intraperitoneal chemotherapy, which involves delivering heated chemotherapy directly into the abdominal cavity during surgery, while others will not receive this additional treatment.

The purpose of this study is to find out whether giving chemotherapy before surgery, with or without the heated chemotherapy treatment during surgery, followed by additional chemotherapy after surgery, helps patients stay free from cancer for a longer time compared to standard treatment. The study will look at whether patients remain disease-free for 36 months after treatment. Patients will be divided into different groups by chance, similar to flipping a coin, and each group will receive a different treatment approach. Some will receive chemotherapy before surgery combined with the heated chemotherapy treatment, some will receive only chemotherapy before surgery, and others will receive standard treatment.

During the study, patients will undergo imaging tests such as CT scan or MRI to monitor their cancer, and blood samples will be collected to look for traces of cancer cells in the bloodstream. The treatment may last up to 24 weeks for some medications, and patients will be followed for several years to see how well the treatment works. The study will measure how long patients live without their cancer returning, how long they survive overall, whether the cancer comes back in the abdominal area specifically, what type of side effects occur, and how much the tumor shrinks in response to treatment before surgery.

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 with systemic chemotherapy

    Your treatment will begin with a combination chemotherapy regimen called FOLFOX. This consists of three medications: oxaliplatin, folinic acid, and fluorouracil.

    These medications will be administered directly into your vein through an intravenous infusion.

    This treatment phase is called neoadjuvant treatment, which means chemotherapy given before surgery to help shrink the tumor.

  2. Step 2

    Possible heated chemotherapy procedure

    Depending on which treatment group you are assigned to, you may receive an additional procedure called HIPEC, which stands for hyperthermic intraperitoneal chemotherapy.

    During this procedure, a heated chemotherapy solution containing mitomycin C is circulated directly into your abdominal cavity.

    This is an intraperitoneal treatment, meaning the medication is delivered directly into the space around your abdominal organs.

    Not all participants will receive this procedure, as it depends on the specific treatment arm of the study.

  3. Step 3

    Surgical removal of the tumor

    After completing the initial chemotherapy treatment, you will undergo surgery to remove the tumor.

    The surgery will be performed after the chemotherapy has had time to work on reducing the size of the tumor.

    The type and extent of surgery will depend on the location and characteristics of your tumor.

  4. Step 4

    Post-surgical chemotherapy treatment

    Following your surgery, you will receive additional chemotherapy treatment. This is called adjuvant treatment, which means chemotherapy given after surgery.

    The medications used may include capecitabine, which is taken by mouth as an oral medication.

    Alternatively, you may continue with intravenous chemotherapy similar to what you received before surgery.

    This treatment aims to eliminate any remaining cancer cells and reduce the risk of the cancer returning.

  5. Step 5

    Follow-up monitoring period

    After completing all treatments, you will be monitored for a period of 36 months (3 years).

    During this time, regular assessments will be performed to check for any signs of cancer recurrence.

    Blood tests may be performed to measure ctDNA, which stands for circulating tumor DNA. This is genetic material from cancer cells that can be detected in your blood.

    Imaging tests such as CT scans or MRI scans may be performed to monitor your condition.

    The monitoring will track whether you remain disease-free, meaning without any evidence of cancer returning.

Who can join the trial?

9 criteria

  • You must be 18 years of age or older and 75 years of age or younger
  • You must have a type of cancer called adenocarcinoma, which is a cancer that starts in gland-like cells, located in your colon (large intestine), sigmoid colon (the S-shaped part of the large intestine), or rectum-sigmoid junction (where the sigmoid colon meets the rectum)
  • Your cancer must be classified as cT4a or cT4b, which means the cancer has grown through the wall of the colon and may have reached nearby organs or tissues, as confirmed by imaging tests such as CT scan (a special X-ray that creates detailed pictures) or MRI (a scan using magnets and radio waves to create images)
  • If your cancer is classified as cT3, you may be included only if the cancer has grown more than 5 millimeters into the surrounding fat tissue
  • Your cancer must not have spread to distant parts of the body, which is called M0 status
  • You must have an ECOG performance status of 0 or 1, which is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work
  • Your cancer must show microsatellite stability, also called pMMR, which means your cancer cells have normal DNA repair function as determined by laboratory testing
  • You must sign an informed consent form, which is a document showing you understand the study and agree to participate
  • If you are able to become pregnant or father a child, you must agree to use a highly effective method of birth control during the study, such as hormonal contraception (pills, patches, vaginal ring), intrauterine device, tubal ligation, vasectomy of your partner, or complete sexual abstinence

Who cannot join the trial?

10 criteria

  • Previous cancer treatment: You cannot participate if you have already received chemotherapy (medicines to treat cancer) or radiation therapy (treatment using high-energy rays) for your current colon cancer.
  • Other cancers: You cannot join if you have had another type of cancer in the past 5 years, except for certain skin cancers that were successfully treated or early-stage cancers that were completely removed.
  • Spread of cancer: You are not eligible if your cancer has spread to distant parts of your body, such as the liver, lungs, or other organs (called metastases).
  • Serious health problems: You cannot participate if you have severe heart disease, kidney disease, or liver disease that would make the treatment unsafe for you.
  • Infections: You are excluded if you have an active serious infection that is not under control.
  • Pregnancy or breastfeeding: You cannot join if you are pregnant or breastfeeding, as the treatment could harm the baby.
  • Allergies to treatment: You are not eligible if you have known severe allergic reactions to the chemotherapy drugs that will be used in the study.
  • Poor general health: You cannot participate if your overall physical condition is too weak to safely undergo the planned treatment and surgery.
  • Blood cell problems: You are excluded if your blood test results show that your body does not have enough healthy blood cells to handle the chemotherapy safely.
  • Mental capacity: You cannot join if you are unable to understand the study information and provide informed consent to participate.
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Investigated drugs

  • FOLFOX

    is a combination of chemotherapy drugs used to treat colon cancer. It is given before surgery in this trial to help shrink the tumor and make it easier to remove. The treatment works by killing cancer cells or stopping them from growing.

  • Mitomycin C

    is a chemotherapy drug that may be used during a special procedure called HIPEC (heated chemotherapy delivered directly into the abdomen during surgery). This medication is heated and applied directly to the area where the cancer is located to kill any remaining cancer cells after the tumor is removed.

What is already known about the treatment

  • FOLFOX

    FOLFOX is a combination chemotherapy regimen given through a vein that includes three different cancer-fighting drugs: folinic acid (leucovorin), fluorouracil, and oxaliplatin, which work together to stop cancer cells from growing and dividing. This treatment is widely used and well-established in medical practice for treating colon and rectal cancers, particularly in advanced stages where the tumor has grown deeply into the bowel wall or spread to nearby lymph nodes. In this clinical trial, FOLFOX is being studied as a neoadjuvant therapy, meaning it is given before surgery to shrink tumors and improve surgical outcomes in patients with locally advanced colon cancer. The medications in this combination work by interfering with DNA production and repair in cancer cells, ultimately leading to their death.

  • Mitomycin C

    Mitomycin C is an anticancer medication that is heated and delivered directly into the abdominal cavity during a specialized procedure called hyperthermic intraperitoneal chemotherapy (HIPEC), which allows high concentrations of the drug to reach cancer cells in the abdomen while minimizing effects on the rest of the body. This drug is an established chemotherapy agent that has been used in cancer treatment for many years, and it works by damaging the DNA inside cancer cells, preventing them from multiplying and causing them to die. In this clinical trial, mitomycin C with HIPEC is being tested as an additional treatment option alongside standard chemotherapy to determine if it can improve outcomes for patients with locally advanced colon cancer that has a high risk of spreading within the abdominal cavity. The medication belongs to a class of drugs called alkylating agents, which chemically modify DNA to stop cancer cell growth.

Investigated diseases

Locally Advanced Adenocarcinoma of the Colon and Upper Rectum – This is a type of cancer that develops in the colon and upper part of the rectum, where cells in the glandular tissue grow abnormally and form tumors. The disease is classified as locally advanced, meaning the tumor has grown through the layers of the intestinal wall and may have spread to nearby lymph nodes, but has not yet spread to distant organs. In this specific form, the cancer shows microsatellite stability, which refers to a particular genetic characteristic of the tumor cells. The tumor penetrates deeply into the intestinal wall, sometimes extending more than 5 millimeters into the surrounding fatty tissue. As the disease progresses, it can involve nearby structures and lymph nodes in the area. Without intervention, the cancer may continue to grow locally and eventually spread to other parts of the body through the bloodstream or lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520471-29-00Protocol codeFCO-FOX-2024-01Estimated enrolment1 083 patientsSponsorFundacion Para La Investigacion Biomedica De Cordoba

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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).