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Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal 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 treatments for locally recurrent rectal cancer, which is a type of cancer that returns in the rectum after initial treatment. The study is comparing two different approaches to treatment. One group of patients will receive a combination of chemotherapy drugs before undergoing chemoradiotherapy, while the other group will receive chemoradiotherapy alone. The chemotherapy drugs being used in this study include Irinotecan Hydrochloride, Calcium Folinate (also known as Folinic Acid), Teysuno (which contains Tegafur, Gimeracil, and Oteracil), Oxaliplatin, Fluorouracil, and Xeloda (which contains Capecitabine).

The purpose of the study is to compare the effectiveness of these two treatment approaches in achieving clear resection margins, which means removing the cancer completely during surgery. Participants in the study will be randomly assigned to one of the two treatment groups. Those in the chemotherapy group will receive the drugs through intravenous infusion or oral tablets over a period of time before starting chemoradiotherapy. The study will monitor the participants' progress and response to the treatments, as well as any side effects they may experience.

Throughout the study, participants will undergo regular assessments to track their health and the status of their cancer. These assessments may include imaging tests like MRI to evaluate the cancer's response to treatment. The study aims to provide valuable information on the best approach to treating locally recurrent rectal cancer, potentially improving outcomes for patients with this condition.

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 study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    Written informed consent is required to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the rectal cancer. This may include imaging tests like MRI to determine if the cancer is resectable.

  3. Step 3

    Induction chemotherapy

    If assigned to the induction chemotherapy group, treatment begins with a combination of medications.

    Medications include irinotecan hydrochloride trihydrate and oxaliplatin, both administered intravenously as a solution for infusion.

    Additional medications such as folinic acid and fluorouracil are given as a solution for injection.

    Oral medications include tegafur, gimeracil, oteracil in capsule form and capecitabine in film-coated tablet form.

    The specific dosage and frequency are determined by the medical team based on individual patient needs.

  4. Step 4

    Chemoradiotherapy

    Following induction chemotherapy, or as the initial treatment for some, chemoradiotherapy is administered.

    This involves a combination of chemotherapy and radiation therapy to target cancer cells more effectively.

  5. Step 5

    Surgical evaluation

    After completing the neoadjuvant treatment, a surgical evaluation is conducted to assess the possibility of resection with clear margins.

    The goal is to determine if the cancer can be surgically removed without leaving any remaining tumor.

  6. Step 6

    Surgery

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

    The success of the surgery is measured by the rate of clear resection margins.

  7. Step 7

    Postoperative follow-up

    Postoperative follow-up includes monitoring for any complications and assessing recovery.

    Additional evaluations may include imaging tests and clinical assessments to check for any signs of cancer recurrence.

  8. Step 8

    Long-term monitoring

    Long-term monitoring is conducted to evaluate overall survival, disease-free survival, and quality of life.

    Regular check-ups and tests are scheduled to ensure ongoing health and to detect any potential issues early.

Who can join the trial?

5 criteria

  • Must be 18 years or older.
  • Must have a confirmed case of locally recurrent rectal cancer. This means the cancer has come back in the rectum area after surgery. Confirmation can be through a lab test called histopathology or by clinical evidence, which includes imaging tests and agreement among medical experts.
  • The cancer must be resectable, meaning it can be removed by surgery. This is determined by a special imaging test called magnetic resonance imaging (MRI) or after treatment with chemoradiotherapy, which is a combination of chemotherapy and radiation therapy. If the cancer is expected to be left behind after surgery or involves certain nerves or bones, it is not considered resectable.
  • Must have a WHO performance score of 0-1. This is a scale used to measure how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides locally recurrent rectal cancer cannot participate. This means the cancer has come back in the same area after treatment.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are part of a vulnerable population, such as those who might not be able to give informed consent, are not eligible.
  • Patients who have medical conditions or are taking medications that could interfere with the study results are excluded.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with severe or uncontrolled health issues that could affect their safety or the study outcomes are excluded.
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Investigated drugs

  • Induction Chemotherapy

    is a treatment used to shrink tumors before the main treatment. In this trial, it is given to patients with locally recurrent rectal cancer to reduce the size of the cancer and make it easier to remove surgically. This approach aims to improve the chances of a successful surgery with clear margins, meaning no cancer cells are left at the edges of the removed tissue.

  • Chemoradiotherapy

    combines chemotherapy and radiation therapy to treat cancer. In this trial, it is used as a neoadjuvant treatment, which means it is given before surgery to help shrink the tumor and kill cancer cells. This combination is intended to enhance the effectiveness of the treatment by using the strengths of both chemotherapy and radiation therapy together.

What is already known about the treatment

  • Induction Chemotherapy

    This treatment is administered intravenously, allowing the medication to enter the bloodstream and target cancer cells throughout the body. It is currently being studied in clinical trials for its effectiveness in treating locally recurrent rectal cancer. The main therapeutic indication is to reduce tumor size before surgery, potentially improving surgical outcomes. At the molecular level, induction chemotherapy works by interfering with the DNA replication of cancer cells, preventing their growth and division. It is classified pharmacologically as an antineoplastic agent.

  • Chemoradiotherapy

    This treatment combines chemotherapy and radiation therapy, administered either orally or intravenously, along with targeted radiation to the affected area. It is a standard treatment option for locally recurrent rectal cancer, with ongoing research to optimize its use. The primary therapeutic indication is to shrink tumors and enhance the effectiveness of surgical resection. The mechanism of action involves chemotherapy sensitizing cancer cells to radiation, which damages their DNA and inhibits their ability to repair, leading to cell death. It is classified as a combination therapy in oncology.

Investigated diseases

Locally Recurrent Rectal Cancer – This condition occurs when rectal cancer returns after initial treatment, typically in the same area where it first developed. The cancer cells may have survived the initial treatment and started to grow again, leading to a recurrence. As the disease progresses, it can cause symptoms similar to the original cancer, such as changes in bowel habits, rectal bleeding, or discomfort. The recurrence can be challenging to manage due to scar tissue from previous treatments and the proximity to other organs. The progression of the disease may vary, and it can potentially spread to nearby tissues or organs. Understanding the nature of the recurrence is crucial for planning further treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512526-28-00Protocol codeNL73593.100.20Estimated enrolment364 patientsSponsorCatharina Ziekenhuis Stichting

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