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Study on Capecitabine and Oxaliplatin for Patients with High Risk 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 High Risk Rectal Cancer. The study involves the use of two medications: Capecitabine and Oxaliplatin. Capecitabine is taken orally, which means it is swallowed in pill form, while Oxaliplatin is given through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of this study is to determine how effective these treatments are in achieving a Pathological Complete Remission (pCR), which means there is no evidence of cancer cells in tissue samples after treatment. The study involves a series of treatments starting with chemotherapy before surgery, followed by a combination of chemotherapy and radiation therapy, and then additional chemotherapy. This approach is designed to shrink the tumor and eliminate cancer cells before surgical removal.

Participants in the study will receive these treatments over a period of time, with regular monitoring to assess the response to the treatment. The study aims to provide valuable information on the effectiveness of this treatment plan for patients with high-risk rectal cancer, potentially improving outcomes and guiding future treatment strategies.

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

    The first phase involves the administration of capecitabine and oxaliplatin as part of the induction chemotherapy.

    Capecitabine is taken orally, while oxaliplatin is given through an intravenous infusion.

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

  2. Step 2

    Pre-operative chemoradiation

    Following the induction chemotherapy, the next phase is pre-operative chemoradiation.

    This involves a combination of chemotherapy and radiation therapy to target the cancer before surgery.

    The aim is to reduce the size of the tumor and improve surgical outcomes.

  3. Step 3

    Consolidation chemotherapy

    After the pre-operative chemoradiation, consolidation chemotherapy is administered.

    This phase is designed to further reduce any remaining cancer cells and enhance the effectiveness of the treatment.

    The specific medications and schedule will be tailored to the patient's condition.

  4. Step 4

    Surgery

    The final step in the trial is surgery to remove the tumor.

    The timing and type of surgery will depend on the response to the previous treatments.

    The goal is to achieve a pathological complete remission, meaning no cancer cells are found in the tissue removed during surgery.

Who can join the trial?

12 criteria

  • Have a specific type of rectal cancer called Medial-distal Rectal Adenocarcinoma, located up to 12 cm from the anal margin, and meet certain stage criteria.
  • No significant heart disease.
  • Not pregnant or breastfeeding.
  • Provide written consent to participate.
  • Be older than 18 years.
  • Have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
  • Have a disease that can be measured according to RECIST 1.1, a standard way to measure how well a cancer treatment works.
  • Understand the risks and benefits of the study.
  • Have certain blood test results within specific ranges, including neutrophils, platelets, bilirubin, ALT, AST, alkaline phosphatase, creatinine clearance, and proteinuria.
  • No complete deficiency of the DPD enzyme, which is important for processing certain chemotherapy drugs. Partial deficiency is allowed with dose adjustments.
  • No severe nerve damage (neuropathy) related to other illnesses.
  • No other cancers in the last 5 years, except for certain skin cancers and cervical cancer that has not spread.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than High Risk Rectal 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.
  • Patients who cannot undergo the required treatments, such as Induction Chemotherapy, radiochemotherapy, or consolidation chemotherapy. These are specific types of cancer treatments.
  • Patients who have any medical condition that might interfere with the study or make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend the necessary appointments.
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Investigated drugs

  • Neoadjuvant Chemotherapy

    is a treatment given before the main treatment, which in this case is surgery. It involves using cancer-fighting drugs to shrink the tumor in the rectum, making it easier to remove during surgery. This approach aims to improve the chances of a successful surgery and reduce the risk of cancer returning.

  • Pre-operative Chemoradiation

    combines chemotherapy and radiation therapy before surgery. The chemotherapy helps make the cancer cells more sensitive to radiation, which can enhance the effectiveness of the radiation therapy. This combination is used to further shrink the tumor and kill any remaining cancer cells, increasing the likelihood of a complete removal during surgery.

  • Consolidation Chemotherapy

    is given after the initial chemotherapy and chemoradiation but before surgery. Its purpose is to eliminate any remaining cancer cells and to consolidate the gains made by the previous treatments. This step is crucial in ensuring that the cancer is as small as possible before the surgical procedure.

What is already known about the treatment

Neoadjuvant Chemotherapy – This treatment is administered intravenously, meaning it is given through a vein, often in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating high-risk rectal cancer. The main therapeutic indication is to shrink tumors before surgery, making them easier to remove. At the molecular level, it works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as an antineoplastic agent, which is a type of medication 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 often 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 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, rectal bleeding, 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 IITrial ID2024-517183-31-00Estimated enrolment93 patientsSponsorCentro Di Riferimento Oncologico Di Aviano

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