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Study on Managing Locally-Advanced Rectal Cancer with Oxaliplatin, Fluorouracil, and Irinotecan Hydrochloride for Patients Responding Well to Initial Chemotherapy

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 treatment of rectal cancer, a type of cancer that affects the last part of the large intestine. The study aims to evaluate a personalized approach to managing this disease after a positive response to initial chemotherapy. The treatment involves several medications, including Oxaliplatin, Fluorouracil, Irinotecan Hydrochloride, Capecitabine, and Calcium Folinate. These medications are commonly used in chemotherapy, which is a treatment method that uses drugs to kill cancer cells.

The purpose of the study is to assess whether a less intensive treatment strategy can be effective for patients who respond well to initial chemotherapy. The study will be conducted in two phases. In the first phase, the focus is on ensuring that the cancer can be surgically removed with a high success rate. In the second phase, the study will look at maintaining the current rate of patients remaining free from cancer for three years. Participants will receive treatment over a period of up to 12 months, with some medications given as infusions, which means they are delivered directly into the bloodstream, and others taken orally as tablets.

Throughout the study, various aspects will be monitored, such as the rate of successful surgeries, the ability to preserve the anal sphincter, and the overall response to treatment. The study will also evaluate the quality of life of participants, including digestive, urinary, and sexual functions, using questionnaires. The safety of the chemotherapy treatments will be assessed using a standard scale to ensure that any side effects are carefully managed. The study is expected to continue until November 2030, with the aim of providing valuable insights into the management of rectal cancer.

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

    Induction chemotherapy

    Receive a combination of medications to treat rectal cancer. These medications include oxaliplatin, fluorouracil, irinotecan hydrochloride, capecitabine, and calcium folinate.

    Medications are administered through infusion or taken orally as prescribed by the healthcare provider.

  2. Step 2

    Evaluation of response

    Undergo assessments to determine the response to the induction chemotherapy.

    The evaluation includes imaging tests to check for tumor regression and ensure no evidence of metastatic disease.

  3. Step 3

    De-escalation treatment strategy

    If a favorable response is observed, a tailored treatment strategy is implemented.

    This strategy aims to maintain a satisfactory surgical outcome while minimizing treatment intensity.

  4. Step 4

    Surgery

    Undergo surgery to remove the tumor, ensuring a clear margin around the tumor site.

    The goal is to achieve an R0 resection, which means no cancer cells are found at the outer edge of the tissue removed.

  5. Step 5

    Post-surgery follow-up

    Participate in regular follow-up appointments to monitor recovery and check for any signs of cancer recurrence.

    Follow-up includes assessments of quality of life, urinary and sexual function, and digestive health.

  6. Step 6

    Long-term monitoring

    Continue to be monitored for up to three years to evaluate disease-free survival and overall survival rates.

    Regular check-ups and tests are conducted to ensure no recurrence of cancer.

Who can join the trial?

7 criteria

  • The patient must have **rectum cancer**.
  • The patient should show a **tumor shrinkage** of 60% or more, and the **CRM** (a margin around the tumor) should be at least 1mm.
  • There should be no clear signs of **cancer spread** to other parts of the body on a **CT-Scan** (a type of detailed imaging test).
  • The patient should be in a general health condition that allows for major surgery in the pelvic area and treatment with a medication called **Capecitabine**.
  • The patient must have normal **blood**, **liver**, **kidney**, and **electrolyte** (ionogram) functions, checked within 7 days before starting the study treatment.
  • The study is open to both **male and female** participants.
  • The study is not specifically for vulnerable populations, meaning it is not designed for groups like children or those unable to consent.

Who cannot join the trial?

4 criteria

  • Patients who have not responded well to the initial treatment called neoadjuvant chemotherapy (NACT). This is a type of cancer treatment given before the main treatment to shrink a tumor.
  • Patients who cannot achieve a satisfactory R0 resection rate. This means the surgery cannot remove all visible cancer.
  • 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

Induction Chemotherapy is a treatment given to shrink a tumor before the main treatment, which is usually surgery. In this trial, it is used for patients with locally-advanced rectal carcinoma to see if they respond well to the chemotherapy before considering other treatment options.

What is already known about the treatment

Induction Chemotherapy – This treatment is typically administered intravenously, allowing the medication to enter the bloodstream directly. It is currently being studied in clinical trials for its effectiveness in treating locally-advanced rectal cancer. The main therapeutic indication is to shrink tumors before surgery, making them easier to remove. At the molecular level, induction chemotherapy works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified pharmacologically as an antineoplastic agent, which is a type of drug used to treat cancer.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511609-44-00Protocol codePROICM 2021-01 GREEstimated enrolment430 patientsSponsorInstitut Regional Du Cancer De Montpellier

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