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Study on Pre-Operative Chemotherapy with Disodium Folinate, Oxaliplatin, and Fluorouracil for Patients with Advanced Resectable 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 is focused on studying the effects of pre-operative treatment in patients with colon cancer. The trial involves patients whose cancer is at an advanced stage, specifically stages T3-4, and/or those with positive lymph nodes as identified by CT or MRI scans, but without cancer spread to distant parts of the body. The purpose of the study is to compare the effectiveness of chemotherapy given before surgery with the standard approach of surgery followed by additional treatment based on the cancer stage.

The study will use several medications, including disodium folinate, Oxaliplatin, Fluorouracil, Irinotecan, Capecitabine, and calcium folinate. These medications are administered either as solutions for infusion, which means they are given directly into the bloodstream, or as tablets taken by mouth. Some participants will receive these medications, while others may receive a placebo. The trial will last for a maximum of 24 months, during which the participants will receive the treatment and be monitored for their response to it.

The main goal is to see if the pre-operative chemotherapy can improve the time patients remain free from the disease, known as disease-free survival. This means the study will look at whether patients have no surgery, no resection, incomplete resection, new metastases, local relapse, or death from any cause after starting the trial. The trial aims to provide valuable information on whether starting treatment before surgery can offer better outcomes for patients with advanced colon cancer.

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 trial

    Upon joining the trial, you will be asked to provide your signed informed consent. This confirms your understanding and agreement to participate in the study.

  2. Step 2

    Initial assessments

    You will undergo initial assessments to ensure you meet the eligibility criteria. This includes blood tests to check your bone marrow, liver, and kidney function, as well as imaging tests like CT or MRI scans to confirm the stage of your colon cancer.

  3. Step 3

    Treatment plan discussion

    A detailed discussion about your treatment plan will take place. The main objective is to compare the effectiveness of chemotherapy before surgery versus surgery followed by chemotherapy.

  4. Step 4

    Preoperative chemotherapy

    If you are assigned to receive chemotherapy before surgery, you will be given medications such as disodium folinate, oxaliplatin, fluorouracil, irinotecan, capecitabine, and calcium folinate. These medications are administered through an infusion, except for capecitabine, which is taken orally. The specific dosage, frequency, and duration will be explained to you by your healthcare team.

  5. Step 5

    Surgery

    After completing the preoperative chemotherapy, you will undergo surgery to remove the cancerous tissue. The timing and specifics of the surgery will be determined by your medical team.

  6. Step 6

    Postoperative care

    Following surgery, you will receive postoperative care to aid your recovery. This may include additional chemotherapy based on the stage of your cancer and your overall health.

  7. Step 7

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include physical exams, blood tests, and imaging studies.

  8. Step 8

    End of trial participation

    Your participation in the trial will conclude after the final follow-up assessments. The results of the trial will contribute to understanding the best treatment approach for advanced colon cancer.

Who can join the trial?

13 criteria

  • Signed informed consent from the patient.
  • Patient must be at least 18 years old.
  • Confirmed diagnosis of adenocarcinoma (a type of cancer) of the colon or upper rectum.
  • Tumor must be mismatch-repair proficient and/or microsatellite stable, which means the tumor has certain genetic characteristics.
  • Intent to have surgery that aims to cure the cancer.
  • Cancer must be at stage T3 or T4 and/or have nodal positivity (N+), which means the cancer has spread to nearby tissues or lymph nodes, as shown by a CT or MRI scan.
  • No evidence of cancer spreading to distant parts of the body, as determined by recent medical evaluations.
  • No significant active wound healing issues, such as severe chronic wounds or untreated bone fractures.
  • Patient must have an ECOG performance status of 0-2, which is a scale used to assess how well a patient can perform daily activities.
  • Patient must have adequate function of bone marrow, liver, and kidneys, as shown by specific blood test results.
  • If not on blood thinners, patient must have certain blood clotting test results within normal limits. Patients on blood thinners are allowed.
  • Patient must have normal fluorouracil metabolism, which means they can process certain chemotherapy drugs without unusual side effects.
  • Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after. Men must also agree to use birth control and not donate sperm during this time.

Who cannot join the trial?

2 criteria

  • Patients with distant metastases (cancer that has spread to other parts of the body) cannot participate.
  • Patients who are not diagnosed with colon cancer staged T3-4 or do not have nodal positive status (cancer that has spread to nearby lymph nodes) by CT or MRI scan are excluded.
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Investigated drugs

Preoperative Chemotherapy is a treatment given before surgery to help shrink the tumor in advanced colon cancer. This therapy involves using drugs that target and kill cancer cells, making it easier to remove the tumor during surgery. The goal is to improve the chances of a successful surgery and reduce the risk of cancer coming back.

What is already known about the treatment

  • Oxaliplatin

    Oxaliplatin is a platinum-based chemotherapy medicine given as an infusion into a vein. It is one of the standard drugs for bowel cancer and forms the backbone of the FOLFOX and FOLFIRINOX regimens used before or after surgery. The platinum atom in the drug binds to the DNA of cancer cells and creates cross-links that block the copying of genetic material, which stops the cells from dividing and leads to their death. It belongs to the group of platinum compounds.

  • Irinotecan

    Irinotecan is a chemotherapy medicine administered as an intravenous infusion and a key component of combination treatment for bowel cancer. It has been in routine use for many years and is derived from a plant substance. It blocks the enzyme topoisomerase I, which cells need to relax their DNA while copying it; the trapped enzyme leaves breaks in the DNA, killing rapidly dividing tumour cells. It is classified as a topoisomerase I inhibitor.

  • Fluorouracil

    Fluorouracil, often called 5-FU, is one of the oldest and most important chemotherapy medicines for cancers of the digestive system and is given as an injection or prolonged infusion into a vein. It remains the foundation of most treatment schedules for colon cancer. It is a false version of a natural building block of DNA and RNA: it blocks the enzyme thymidylate synthase and becomes incorporated into the genetic material of cancer cells, preventing them from growing and dividing. It belongs to the antimetabolite group of pyrimidine analogues.

  • Capecitabine

    Capecitabine is a chemotherapy medicine taken as tablets by mouth, which makes treatment possible at home. It is widely used for colon, rectal, stomach and breast cancer. It is a prodrug: after swallowing it travels through the body in an inactive form and is converted into fluorouracil mainly inside tumour tissue, where it then blocks DNA production in the cancer cells. It is classified as a fluoropyrimidine antimetabolite.

  • Folinic acid

    Folinic acid, given in this trial as its calcium or disodium salt, is a supportive medicine administered as an infusion into a vein together with fluorouracil. It is an active form of the vitamin folate and has been used in oncology for decades. It does not attack the tumour itself; instead it stabilises the bond between fluorouracil and its target enzyme inside cancer cells, making the chemotherapy considerably more effective. It is classified as a chemotherapy-enhancing and protective agent.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. 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. The disease progresses as the cancer cells grow and invade the walls of the colon, potentially spreading to nearby lymph nodes. In advanced stages, colon cancer can spread to other parts of the body, such as the liver or lungs. The progression of the disease is often categorized by stages, with T3-4 indicating more advanced local growth and nodal involvement suggesting spread to nearby lymph nodes.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508076-11-00Protocol codePROTECTOR/FIRE-10Estimated enrolment714 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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