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Study on Organ Preservation in Advanced Rectal Cancer Using Oxaliplatin, Fluorouracil, and Calcium Folinate for Patients with Confirmed 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 focuses on studying the treatment of rectal cancer, a type of cancer that affects the last part of the large intestine. The study aims to explore the effects of a combination of treatments, including radiochemotherapy followed by consolidation chemotherapy. Radiochemotherapy involves using both radiation and chemotherapy to target cancer cells, while consolidation chemotherapy is additional treatment given to strengthen the initial therapy's effects.

The medications used in this study include Oxaliplatin, Fluorouracil, and Calcium Folinate Pentahydrate. Oxaliplatin is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein. Fluorouracil is provided as a solution for injection, also delivered intravenously. Calcium Folinate Pentahydrate is used as a solution for injection or infusion, supporting the other medications by reducing their side effects and enhancing their effectiveness.

The purpose of this study is to estimate the effect of the treatment regimen on locally advanced rectal cancer. Participants will undergo a series of treatments over a period of up to 12 months. The study will assess the response of the cancer to the treatment, aiming to understand how well the combination of therapies works in preserving the organ and controlling the disease. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study is designed to gather information that could lead to improved treatment strategies for rectal cancer in the future.

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

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a detailed medical history review, physical examination, and specific tests such as high-resolution magnetic resonance imaging (MRI) of the pelvis and cross-sectional imaging of the abdomen and chest to ensure there are no distant metastases.

  3. Step 3

    Radiochemotherapy phase

    You will undergo a combination of radiation therapy and chemotherapy. The chemotherapy involves the administration of three medications: oxaliplatin, fluorouracil, and calcium folinate pentahydrate. These medications are given through an intravenous infusion, which means they are delivered directly into your bloodstream through a vein.

    The specific dosage and frequency of these medications will be determined by the medical team based on your individual health status and response to treatment.

  4. Step 4

    Consolidation chemotherapy phase

    Following the radiochemotherapy phase, you will receive additional chemotherapy to consolidate the treatment effects. This phase aims to enhance the response to the initial treatment and further reduce the cancer cells.

    The same medications, oxaliplatin, fluorouracil, and calcium folinate pentahydrate, will be used during this phase, administered intravenously.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and manage any side effects. This includes routine blood tests, imaging studies, and clinical evaluations.

    After completing the treatment phases, follow-up visits will be scheduled to monitor your health status and the long-term effects of the treatment.

Who can join the trial?

17 criteria

  • Both men and women can participate.
  • Must have a confirmed diagnosis of rectal cancer.
  • The cancer should be located between 0 to 12 cm from the anal area, as measured by a procedure called rigid rectoscopy.
  • Must have specific stages of cancer as determined by an MRI scan (a detailed imaging test).
  • Must undergo a high-resolution MRI of the pelvis for local staging.
  • Must have imaging tests of the abdomen and chest to ensure the cancer has not spread to other parts of the body.
  • Must be at least 18 years old. There is no upper age limit.
  • Must have a WHO/ECOG Performance Status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate blood, liver, kidney, and metabolic function, including:
    • Leukocytes (a type of white blood cell) count of at least 3,000/mm3
    • ANC (Absolute Neutrophil Count) of at least 2,000/mm3
    • Platelets count of at least 100,000/mm3
    • Hemoglobin (Hb) level greater than 9 g/dl
    • Serum creatinine level no more than 1.5 times the upper limit of normal
    • Creatinine clearance of at least 30 ml/min
    • Bilirubin level no more than 2.0 mg/dl
    • SGOT-SGPT and AP levels no more than 3 times the upper limit of normal
    • Must provide informed consent, meaning you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of rectal cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible for radiochemotherapy or consolidation chemotherapy.
  • Patients who are part of a vulnerable population that cannot safely participate in the study.
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Investigated drugs

  • Radiotherapy

    is a treatment that uses high-energy rays, similar to X-rays, to target and kill cancer cells. In this trial, radiotherapy is used to shrink the tumor in the rectum before other treatments are applied. It helps to make the cancer smaller and easier to treat with other therapies.

  • Chemotherapy

    involves using special drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used alongside radiotherapy to enhance the effect of the treatment. It helps to attack the cancer cells more effectively and can also help prevent the cancer from spreading to other parts of the body.

What is already known about the treatment

Radiochemotherapy – Radiochemotherapy is a treatment method that combines radiation therapy with chemotherapy to treat cancer, specifically rectal cancer in this trial. It is administered by delivering radiation to the cancerous area while simultaneously giving chemotherapy drugs, which can be taken orally or injected. This combination aims to enhance the effectiveness of treatment by using radiation to damage cancer cells and chemotherapy to prevent them from repairing and growing. Radiochemotherapy is currently being studied for its potential to preserve organs in patients with locally advanced rectal cancer, as part of a phase II pilot trial by the German Rectal Cancer Study Group.

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. The progression of rectal cancer can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The disease is often classified by stages, which describe the extent of cancer spread within the body. Early detection and monitoring of changes in the rectum are crucial for managing the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517928-19-00Protocol codeCAO/ARO/AIO-16Estimated enrolment89 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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