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Study of CAPOX or FOLFOX chemotherapy before surgery in patients with obstructive colon cancer treated with colostomy

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 treating patients with obstructive colon cancer who have undergone initial treatment with a temporary opening in the abdomen (stoma) to relieve the blockage. The study aims to determine if giving chemotherapy before surgery can improve treatment outcomes compared to giving chemotherapy after surgery.

The treatment involves different combinations of chemotherapy medications including oxaliplatin, fluorouracil, capecitabine, and levoleucovorin. These medications are given either as tablets taken by mouth or as solutions administered through a vein. The chemotherapy combinations used in this study are known as CAPOX and FOLFOX.

The treatment period lasts up to 6 months, during which patients receive regular doses of chemotherapy medications. Throughout the study, patients will need to undergo various medical examinations and tests to monitor their health and response to treatment. The success of the treatment will be measured by how many patients can complete the entire planned treatment sequence.

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 assessment

    After confirmation of colon cancer that blocks the intestine, a temporary opening (stoma) will be created to relieve the blockage

    Medical tests will be performed to confirm eligibility, including blood tests and CT scan of chest, abdomen, and pelvis

    Laboratory tests must show adequate blood cell counts, liver function, and kidney function

  2. Step 2

    Treatment assignment

    You will be assigned to receive one of two chemotherapy combinations:

    Option 1 (CAPOX): Oxaliplatin by injection plus Capecitabine tablets

    Option 2 (FOLFOX): Oxaliplatin, Fluorouracil, and Levoleucovorin by injection

  3. Step 3

    Pre-surgery chemotherapy

    Chemotherapy will be given before the main surgery to remove the cancer

    Regular monitoring of your health status will be performed during treatment

    Monthly pregnancy tests are required for women of childbearing potential

  4. Step 4

    Surgery

    Surgery will be performed to remove the affected part of the colon

    The temporary stoma may be closed during this procedure if appropriate

  5. Step 5

    Follow-up period

    Regular check-ups will continue after surgery

    Women must use birth control during treatment and for 15 months after completion

    Men must use birth control during treatment and for 12 months after completion

Who can join the trial?

18 criteria

  • Must be at least 18 years old
  • Must have good physical performance status (ECOG 0 or 1 - able to carry out normal activities with minimal symptoms)
  • Must have been treated with a defunctioning stoma (temporary opening in the abdomen to relieve bowel obstruction) for obstructive colon cancer
  • Must have confirmed adenocarcinoma (type of cancer) located at least 10 cm from the anal opening
  • Must need surgery to remove part of the colon
  • Must meet specific blood test requirements, including:
    • Adequate white blood cell and platelet counts
    • Acceptable hemoglobin levels
    • Normal liver and kidney function tests
    • Must have cancer that has not spread to other parts of the body (non-metastatic)
    • Must not have a second colon cancer
    • Must not have had previous chemotherapy or radiation to the abdomen or pelvis
    • Must not have had previous colorectal cancer
    • Must not have serious medical conditions that could interfere with treatment
    • Women who can become pregnant must use effective contraception during treatment and for 15 months after
    • Men must use contraception during treatment and for 12 months after
    • Must be able to follow study requirements
    • Must have health insurance
    • Must provide informed consent

Who cannot join the trial?

15 criteria

  • Age under 18 or over 75 years old
  • Presence of distant metastases (cancer spread to other parts of the body)
  • Previous chemotherapy or radiation therapy for colon cancer
  • Presence of other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Severe heart conditions including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within past 6 months
    • Severe kidney dysfunction
    • Severe liver dysfunction
    • Active, uncontrolled infection
    • Known allergy to any of the study medications
    • Pregnancy or breastfeeding
    • Inability to follow study procedures
    • Participation in another clinical trial within the past 30 days
    • Mental conditions that could interfere with study participation or consent
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Investigated drugs

CAPOX A combination chemotherapy treatment that includes capecitabine and oxaliplatin. This medication is used to treat colon cancer before surgery (neoadjuvant therapy). It is taken partly as tablets and partly through an intravenous infusion. FOLFOX A combination chemotherapy treatment that includes fluorouracil, leucovorin, and oxaliplatin. This medication is used to treat colon cancer before surgery (neoadjuvant therapy). It is given through an intravenous infusion over several hours. Both these treatments are standard chemotherapy combinations used in colorectal cancer treatment, with the main difference being how they are administered to patients. They work by stopping or slowing down the growth of cancer cells.

What is already known about the treatment

  • CAPOX

    A chemotherapy combination treatment consisting of capecitabine (taken orally) and oxaliplatin (given intravenously), used in the treatment of colorectal cancer, particularly in cases of obstructive colon cancer. This medication regimen works by interfering with cancer cell DNA replication and division, effectively stopping tumor growth. CAPOX belongs to the class of combined antineoplastic agents and is commonly used in both neoadjuvant (before surgery) and adjuvant (after surgery) settings.

  • FOLFOX

    A chemotherapy combination that includes fluorouracil, leucovorin, and oxaliplatin, administered intravenously for the treatment of colorectal cancer. This medication protocol works by disrupting cancer cell division and DNA synthesis through multiple mechanisms, making it an effective treatment for colon cancer. FOLFOX is classified as a combined antineoplastic regimen and is widely used in clinical practice as both pre-surgical (neoadjuvant) and post-surgical (adjuvant) therapy.

Investigated diseases

Colorectal Cancer (Obstructive) - A form of cancer that develops in the large intestine (colon), specifically characterized by a tumor that blocks the normal passage of contents through the colon. The blockage typically develops gradually as the tumor grows inward from the colon wall. This condition can cause the colon to become distended above the blockage. The disease begins when healthy cells in the colon develop changes in their DNA and grow uncontrollably, forming a mass. As the tumor increases in size, it can eventually narrow the intestinal passage to the point of obstruction.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516456-17-00Protocol code2019/0407/HPEstimated enrolment232 patientsSponsorCentre Hospitalier Universitaire Rouen

sourced from the EU Clinical Trials Register and site verification

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