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Study on the Effectiveness of Heated Chemotherapy with Mitomycin-C for Patients with Colon Cancer Spread to the Peritoneum After Surgery

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 is focused on studying a treatment for patients with peritoneal metastases of colorectal cancer. The treatment being tested is called hyperthermic intraoperative chemotherapy (HIPEC) using a drug named Mitomycin-C. This drug is administered directly into the abdominal area during surgery after the visible cancer has been removed. The purpose of the study is to evaluate whether this treatment can help reduce the recurrence of cancer in the abdominal area.

Participants in the study will be divided into two groups. One group will receive the HIPEC treatment with Mitomycin-C, while the other group will not receive this additional treatment. The study will monitor the participants over several years to see if there are differences in how often the cancer returns in the abdomen. The study will also look at overall cancer recurrence, survival rates, and any complications that may arise after the surgery.

Throughout the study, the quality of life of the participants will be assessed using specific questionnaires. The study aims to provide valuable information on whether adding HIPEC with Mitomycin-C to the surgical treatment can improve outcomes for patients with this type of cancer. The study is expected to continue until 2027, with participants being monitored for up to three years after their treatment.

The research process

The trial runs in 6 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 a diagnosis of colon cancer with peritoneal metastases and the absence of other metastases.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Surgical procedure

    A surgical procedure is performed to remove visible tumors. This is known as complete surgical debulking.

    The goal is to achieve a macroscopically complete surgical cytoreduction, meaning no visible tumor remains.

  3. Step 3

    Hyperthermic intraoperative chemotherapy (HIPEC)

    During the surgery, a heated chemotherapy treatment called HIPEC is administered directly into the abdominal cavity.

    The chemotherapy drug used is Mitomycin-C, delivered in a solution for injection or infusion.

  4. Step 4

    Postoperative care

    After the surgery and HIPEC, recovery and monitoring occur in a hospital setting.

    Postoperative complications are assessed using a standardized classification system.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health and check for any recurrence of cancer.

    Assessments include overall survival, recurrence rates, and quality of life evaluations using specific questionnaires.

  6. Step 6

    Study duration

    The study is conducted over several years, with primary endpoints evaluated at 1, 2, and 3 years.

    The estimated end date for the study is January 1, 2027.

Who can join the trial?

8 criteria

  • The patient must have colon cancer confirmed by a test called a histology, but not a type with more than 50% signet ring cells, which is a rare form of colon cancer.
  • The patient should not have cancer that has spread outside the belly area, such as to distant lymph nodes, liver, or lungs. This is checked with a scan called a PET if needed.
  • The patient can have cancer spread within the belly area, but it should be mild or moderate, with a score called PCI of 20 or less. This is checked during surgery.
  • The patient must have a surgery that removes all visible cancer, known as a complete surgical cytoreduction, checked during surgery.
  • The patient should receive chemotherapy, which is a type of cancer treatment, either before or after surgery.
  • The patient must be older than 18 years.
  • The patient should be healthy enough for surgery, with an acceptable risk level. This is measured by ASA and ECOG scores, which assess overall health and ability to perform daily activities, and by checking blood, kidney, and liver function.
  • The patient must be informed about the study and agree to participate by signing a document called the Informed Consent.

Who cannot join the trial?

3 criteria

  • Patients who have other types of cancer besides **colorectal cancer** with **peritoneal metastases**. **Peritoneal metastases** means that the cancer has spread to the lining of the abdomen.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Mitomycin-C is a medication used in this clinical trial as part of a treatment called hyperthermic intraoperative chemotherapy (HIPEC). It is administered directly into the abdominal cavity during surgery to target and kill cancer cells that may remain after the surgical removal of tumors. This approach aims to reduce the risk of cancer recurrence in patients with peritoneal metastases from colon cancer.

What is already known about the treatment

Mitomycin-C – This medication is administered through a method called hyperthermic intraoperative chemotherapy (HIPEC), which involves applying the drug directly into the abdominal cavity during surgery. It is currently being studied in a Phase IV clinical trial to assess its effectiveness in treating peritoneal metastases of colorectal cancer. The main therapeutic indication for Mitomycin-C in this context is to reduce the recurrence of cancer in the peritoneal area after surgical removal of tumors. At the molecular level, Mitomycin-C works by cross-linking DNA, which inhibits DNA synthesis and ultimately leads to cell death. It is classified as an antineoplastic antibiotic, used primarily in cancer treatment.

Investigated diseases

Colorectal Cancer – This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body, including the liver and lungs. The progression of colorectal cancer can vary, with some cases remaining localized while others spread more aggressively. Early stages may not show symptoms, but as it advances, symptoms like changes in bowel habits, blood in stool, and abdominal discomfort may occur.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512726-28-00Protocol codeGECOP-MMCEstimated enrolment216 patientsSponsorHospital Universitario De Fuenlabrada

sourced from the EU Clinical Trials Register and site verification

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