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Study on Chemotherapy and Pelvic Reirradiation for Patients with Recurrent Rectal Cancer Using Irinotecan, Levoleucovorin, Fluorouracil, Oxaliplatin, and Capecitabine

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 treatments for rectal cancer, specifically when it has returned after initial treatment. The study is comparing two approaches: one group will receive chemotherapy followed by a second round of radiation therapy to the pelvic area, while the other group will receive chemotherapy alone. The chemotherapy medications being used in this study include irinotecan hydrochloride trihydrate (known as CampTO), levoleucovorin (known as Elvorine), fluorouracil (known as Fluorouracile Accord), oxaliplatin (known as Eloxatine), and capecitabine (known as Xeloda). These medications are administered either through an intravenous infusion, which means they are given directly into a vein, or as oral tablets.

The purpose of this study is to determine if adding radiation therapy to chemotherapy can improve the chances of successful surgery to remove the cancer. Participants in the study will receive treatment over a period of several months, with regular check-ups to monitor their health and the effectiveness of the treatment. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study will also look at how well patients tolerate the treatment and any side effects they may experience.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI to evaluate the size of the tumor and determine the response to treatment. The study aims to improve the understanding of how to best treat recurrent rectal cancer and enhance the quality of life for patients undergoing these treatments. The trial is expected to continue until the end of 2025, with ongoing evaluations of treatment outcomes and patient well-being.

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

    Initial chemotherapy phase

    The treatment begins with the administration of chemotherapy drugs. These include irinotecan hydrochloride trihydrate, levoleucovorin, fluorouracil, and oxaliplatin. These medications are given through an intravenous infusion.

    The frequency and dosage of these medications will be determined by the medical team based on individual patient needs and responses.

  2. Step 2

    Oral medication phase

    In addition to the intravenous medications, capecitabine is administered in the form of film-coated tablets.

    The dosage and frequency of capecitabine will be specified by the healthcare provider.

  3. Step 3

    Evaluation and monitoring

    Throughout the treatment, regular evaluations are conducted to monitor the response to the chemotherapy.

    These evaluations may include imaging tests and blood tests to assess the size of the tumor and overall health.

  4. Step 4

    Pre-operative assessment

    After completing the chemotherapy, a pre-operative assessment is performed to determine the feasibility of surgery.

    This assessment includes reviewing the reduction in tumor size and overall health status.

  5. Step 5

    Surgical intervention

    If the tumor is deemed resectable, surgery is scheduled to remove the cancerous tissue.

    The goal of the surgery is to achieve a curative resection, meaning the complete removal of the tumor.

  6. Step 6

    Post-operative care and follow-up

    Following surgery, post-operative care is provided to ensure recovery and monitor for any complications.

    Regular follow-up visits are scheduled to assess recovery, manage any side effects, and monitor for recurrence of cancer.

Who can join the trial?

13 criteria

  • Must have signed and dated an informed consent form, which means you agree to participate in the study after understanding what it involves.
  • Have an ECOG performance status of less than 2, which is a scale used to assess how well you can perform daily activities. A score of less than 2 means you are able to carry out most activities.
  • If you are a woman who is not sterilized or a man, you must agree to use two effective methods of birth control during the study, including one barrier method, for at least 6 months after the last treatment.
  • Must be part of a social security system or have similar benefits.
  • Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and other procedures required by the study.
  • Must be 18 years of age or older.
  • Have a first or second locally recurrent rectal cancer (LRRC) that is 15 cm or less from the anal verge, which means the cancer has returned in the rectum area.
  • Have had previous radiation treatment to the pelvic area for the initial rectal cancer or its first recurrence, with a dose between 25-50.4Gy.
  • No distant metastasis, meaning the cancer has not spread to other parts of the body.
  • The recurrent rectal cancer must be resectable, meaning it can be surgically removed, according to specific medical guidelines.
  • Must have adequate hematologic function, which means having enough healthy blood cells: hemoglobin of at least 9 g/dL, neutrophil count of at least 1500/mm3, and blood platelets of at least 100,000/mm3.
  • Must have adequate hepatic function, meaning the liver is working well: total bilirubin of 1.5 times the upper limit of normal (ULN) or less, and ASAT and ALAT levels of 3 times ULN or less.
  • Must have adequate renal function, meaning the kidneys are working well, with a creatinine clearance of at least 30 ml/min.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated with radiation therapy for rectal cancer.
  • Patients who have other types of cancer that are not related to rectal cancer.
  • Patients who are unable to undergo surgery for any reason.
  • Patients with severe medical conditions that could make participation in the study unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are participating in another clinical trial that could interfere with this study.
  • Patients who have allergies or reactions to the medications used in the study.
  • Patients with a history of certain heart conditions that could be worsened by the study treatments.
  • Patients with severe liver or kidney problems that could affect how the body handles the study medications.
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Investigated drugs

  • Neoadjuvant Chemotherapy

    is a treatment given before the main treatment, in this case, surgery. It involves using drugs to shrink or control the growth of cancer. This approach aims to make the tumor smaller and easier to remove during surgery. In this trial, chemotherapy is used to treat locally recurrent rectal cancer.

  • Pelvic Reirradiation

    is a therapy that involves using high-energy rays to target and kill cancer cells in the pelvic area. This treatment is used after initial radiation therapy if the cancer returns. In this trial, pelvic reirradiation is combined with chemotherapy to see if it improves the chances of successful surgery compared to chemotherapy alone.

What is already known about the treatment

Neoadjuvant Chemotherapy – This treatment is administered intravenously, allowing the medication to enter the bloodstream directly. It is currently being evaluated in clinical trials for its effectiveness in treating locally recurrent rectal cancer. The main therapeutic indication is to shrink tumors before surgery, potentially increasing the chances of complete removal. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and division. It is classified as an antineoplastic agent, commonly used in cancer treatment to reduce tumor size and prevent cancer spread.

Investigated diseases

  • Recurrent Rectal Cancer After Local Excision

    This condition occurs when rectal cancer returns after it has been surgically removed from the rectum. The cancer cells may have been left behind or spread to nearby tissues, leading to a recurrence. It can cause symptoms similar to the initial cancer, such as changes in bowel habits, rectal bleeding, or discomfort. The progression of recurrent rectal cancer can vary, with some cases remaining localized while others may spread to other parts of the body. The recurrence often requires additional treatment strategies to manage the disease. Monitoring and follow-up are crucial to detect any changes in the condition.

  • Rectal Cancer

    This type of cancer originates in the rectum, the last several inches of the large intestine before the anus. It typically begins as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. As the cancer progresses, it can invade deeper layers of the rectum and potentially spread to nearby lymph nodes and other organs. The progression can vary significantly among individuals, with some experiencing slow growth and others facing more aggressive disease. Early detection and monitoring are important for managing rectal cancer effectively.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514705-62-00Protocol codeCHUBX 2017/52Estimated enrolment186 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

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