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Study on Oxaliplatin and Capecitabine for Patients with Locally Advanced Rectal Cancer

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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 a type of cancer called locally advanced rectal cancer, specifically a form known as adenocarcinoma that occurs in the middle or lower part of the rectum. The study is investigating a treatment approach that does not involve surgery. Instead, it uses a combination of medications and therapies to treat the cancer. The medications being studied are Oxaliplatin and Capecitabine, which are both chemotherapeutic drugs. These drugs are used to kill cancer cells or stop them from growing and spreading.

The purpose of the study is to determine if this non-surgical treatment approach is effective in preventing the cancer from coming back in other parts of the body. Participants in the study will receive a combination of treatments, including Induction Chemotherapy (ICT) and Chemo-Radiotherapy (CRT), followed by a period of close monitoring without surgery. The study will also look at various markers in the blood and tissue to understand how the treatment affects the cancer and the surrounding tissue.

Throughout the study, participants will be closely monitored to assess their response to the treatment. The study aims to evaluate the rate of complete response, meaning the cancer is no longer detectable, as well as the overall survival and quality of life of the participants. The study will also track any recurrence of the cancer and the ability to preserve the organs affected by the cancer. This research hopes to provide valuable insights into the effectiveness of non-surgical treatments for locally advanced rectal cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction chemotherapy

    Receive oxaliplatin through an infusion. This medication is administered to help shrink the tumor before further treatment.

    The dosage and frequency of administration will be determined by the medical team based on individual health conditions and response to treatment.

  2. Step 2

    Chemo-radiotherapy

    Undergo a combination of chemotherapy and radiotherapy. This phase aims to further reduce the tumor size and eliminate cancer cells.

    The specific schedule and duration of this treatment will be provided by the healthcare provider.

  3. Step 3

    Non-operative management (NOM)

    Participate in a period of intensive follow-up without surgery. This approach monitors the tumor's response to the previous treatments.

    Regular assessments will be conducted to evaluate the tumor's status and ensure no progression.

  4. Step 4

    Intensive follow-up

    Attend scheduled follow-up appointments to monitor health and detect any signs of cancer recurrence.

    These appointments may include physical exams, imaging tests, and laboratory tests as necessary.

Who can join the trial?

13 criteria

  • Must have a confirmed diagnosis of **adenocarcinoma** of the medium or lower rectum. Adenocarcinoma is a type of cancer that forms in mucus-secreting glands.
  • Must have a **Stage II** (cT3-4 N0) or **Stage III** (cT1-4, N1-2) tumor. These stages describe the size and spread of the cancer.
  • Cancer should be locally advanced and suitable for a surgery called **Total Mesorectal Excision (TME)** or **Abdominal-Perineal Amputation**.
  • No signs of cancer spread to other parts of the body, confirmed by a special scan of the chest, abdomen, and pelvis. An alternative scan is allowed if allergic to certain contrast materials.
  • No previous radiation therapy to the pelvic area.
  • No previous cancer treatments or surgeries for rectal cancer.
  • Must be older than 18 years.
  • No infections that need treatment with antibiotics.
  • Must have a **performance status** of 0-1 on the **ECOG Scale**, which measures daily living abilities.
  • Blood tests must show: **ANC** (a type of white blood cell) > 1.5 cells/mm3, **Hemoglobin** > 8.0 g/dL, **Platelets** > 150,000/mm3, **Total bilirubin** ≤ 1.5 times the normal limit, **AST** and **ALT** (liver enzymes) ≤ three times the normal limit, and **Serum creatinine** ≤ 1.5 times the normal limit.
  • Must read, agree to, and sign an **Informed Consent** form before joining the study.
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control methods.
  • Men must also agree to use effective birth control methods.

Who cannot join the trial?

5 criteria

  • Patients with a different type of cancer than the one being studied cannot participate.
  • Patients whose cancer is not in the specified stages (Stage II or Stage III) are not eligible.
  • Patients who are not able to undergo the specific treatments being studied, such as **Induction ChemoTherapy (ICT)** or **Chemo-RadioTherapy (CRT)**, cannot join the trial. **ChemoTherapy** is a treatment using drugs to kill cancer cells, and **RadioTherapy** uses high-energy rays to target cancer.
  • Patients who cannot commit to the intensive follow-up schedule required by the study are not eligible.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not included in this study.
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Investigated drugs

  • Induction Chemotherapy (ICT)

    is a treatment approach used in this trial to shrink the tumor before other therapies. It involves using powerful drugs to target and kill cancer cells, aiming to reduce the size of the tumor and make it more manageable for subsequent treatments.

  • Chemo-Radiotherapy (CRT)

    combines chemotherapy and radiation therapy to enhance the effectiveness of treatment. Chemotherapy drugs make cancer cells more sensitive to radiation, which helps in destroying the tumor more effectively. This combination is used to maximize the chances of eliminating the cancer cells in the rectal area.

  • NOM (Non-Operative Management)

    is a strategy where surgery is not performed after the initial treatments if the tumor shows a complete response. Instead, patients are closely monitored with regular check-ups and imaging tests to ensure the cancer does not return. This approach aims to avoid the risks and complications associated with surgery while still effectively managing the cancer.

What is already known about the treatment

  • Induction Chemotherapy (ICT)

    This treatment is 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, specifically adenocarcinoma of the medium to lower rectum in Stage II or III. The main therapeutic indication is to reduce tumor size and prevent distant relapse. At the molecular level, ICT works by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and division. It is classified pharmacologically as a cytotoxic chemotherapy agent.

  • Chemo-Radiotherapy (CRT)

    This treatment combines chemotherapy and radiation therapy, administered either orally or intravenously, along with targeted radiation to the tumor site. It is under investigation in clinical trials for its potential to treat locally advanced rectal cancer without the need for surgery. The primary therapeutic indication is to enhance tumor response and control local disease. The mechanism of action involves chemotherapy sensitizing cancer cells to radiation, which damages their DNA and prevents them from multiplying. CRT is classified as a combination therapy involving both chemotherapeutic and radiotherapeutic agents.

Investigated diseases

Adenocarcinoma of the Rectum – This is a type of cancer that begins in the glandular cells lining the rectum, which is the last part of the large intestine. It is classified into stages based on how far it has spread, with Stage II indicating deeper invasion into the rectal wall and Stage III involving nearby lymph nodes. The disease typically progresses by growing into surrounding tissues and potentially spreading to other parts of the body. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression can vary, with some cases remaining localized while others may spread to distant organs. Regular monitoring and follow-up are crucial to manage the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515225-28-00Protocol codeNO-CUT TRIALEstimated enrolment180 patientsSponsorASST Grande Ospedale Metropolitano Niguarda

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).