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Study on Post-Surgery Treatment for Colon Cancer Patients Using Trifluridine, Irinotecan, and Drug Combination

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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 patients with colon cancer, specifically those who have undergone surgery for stage III or high-risk stage II colon cancer. The study aims to explore the effectiveness of different treatment combinations in clearing circulating tumor DNA (ct-DNA) from the blood, which is a marker that can indicate the presence of cancer cells. The trial involves several medications, including FOLFOXIRI, FOLFOX, CAPOX, Trifluridine/Tipiracil, Trastuzumab, and Tucatinib. These treatments are used in various combinations to determine their impact on ct-DNA levels after surgery.

The study is divided into two parts. In the first part, patients receive adjuvant therapy, which is additional treatment given after surgery to help prevent cancer from returning. This part of the study compares the effectiveness of FOLFOXIRI against FOLFOX/CAPOX, and for a specific group of patients with HER2-positive/RAS wild-type colon cancer, it compares FOLFOX plus Trastuzumab and Tucatinib. The second part of the study focuses on post-adjuvant treatment, which is given after the initial adjuvant therapy. In this phase, the study examines the effects of Trifluridine/Tipiracil compared to observation, meaning no additional treatment, in patients who still have positive ct-DNA after completing their initial therapy.

Throughout the study, patients will receive their treatments either orally or through intravenous use, depending on the medication. The trial will monitor the rate at which ct-DNA is cleared from the blood, as well as any side effects experienced by participants. The goal is to find the most effective treatment strategy to reduce the risk of cancer recurrence in patients with resected colon cancer. The study is expected to continue until 2028, providing valuable insights into the management of colon cancer post-surgery.

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

    Adjuvant treatment initiation

    The trial begins with the adjuvant treatment phase for patients with stage III or high-risk stage II colon cancer.

    Patients receive a combination of medications, including FOLFOXIRI or FOLFOX/CAPOX, which are chemotherapy regimens. These regimens include drugs such as oxaliplatin, fluorouracil, and leucovorin.

    The treatment aims to clear circulating tumor DNA (ct-DNA) detected after surgery.

  2. Step 2

    Target-driven adjuvant treatment

    For patients with specific genetic markers (HER2+ and RAS wild-type), an additional treatment option is available.

    This involves the use of trastuzumab and tucatinib in combination with the FOLFOX regimen.

    The goal is to enhance the clearance of ct-DNA in these patients.

  3. Step 3

    Post-adjuvant treatment

    After completing the adjuvant treatment, patients with positive ct-DNA may enter the post-adjuvant phase.

    This phase involves treatment with trifluridine/tipiracil, which is administered orally.

    The objective is to further reduce ct-DNA levels and monitor for any adverse effects.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, patients undergo regular monitoring to assess the effectiveness of the treatment and any side effects.

    This includes blood tests to measure ct-DNA levels and imaging studies to check for disease progression.

    The trial aims to determine the rate of ct-DNA clearance and overall survival outcomes.

Who can join the trial?

16 criteria

  • Must provide written consent to participate in the study.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of stage III or high-risk stage II colon cancer. High-risk stage II is defined by certain factors like tumor size or specific symptoms.
  • Must have completed a specific type of cancer treatment involving drugs like fluoropyrimidine and oxaliplatin for at least 3 months and no more than 6 months.
  • Must have a CT scan or MRI of the chest and abdomen within 4 weeks after finishing treatment, showing no spread of cancer.
  • Must have a blood test showing positive results for **ct-DNA**, which is a type of DNA found in the blood after cancer treatment.
  • Must have certain blood test results within normal limits, including bilirubin, liver enzymes, and kidney function.
  • Must have a sample of the tumor tissue available for analysis.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Participants and their partners must agree to use effective birth control during the study and for 180 days after the last dose of chemotherapy.
  • Must be willing and able to follow the study procedures.
  • For a specific part of the study, must have a certain type of cancer called **HER2+** and **RAS wt**, which are specific genetic characteristics of the tumor.
  • Must have had surgery to remove the cancer between 4 and 12 weeks before joining the study.
  • Must have a CT scan or MRI after surgery showing no spread of cancer.
  • Must have a blood sample taken 2-6 weeks after surgery showing positive **ct-DNA**.
  • Must have certain blood cell counts within normal limits, including neutrophils, platelets, and hemoglobin.

Who cannot join the trial?

6 criteria

  • Patients who do not have **Stage III** or **high-risk Stage II** colon cancer.
  • Patients who have not had surgery to remove their colon cancer.
  • Patients who do not have **positive ct-DNA** after surgery. **ct-DNA** is a type of DNA found in the blood that can come from cancer cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to receive the specific treatments being tested in the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • FOLFOXIRI

    is a combination chemotherapy regimen used to treat colon cancer. It includes three main drugs: fluorouracil, leucovorin, and irinotecan, along with oxaliplatin. This combination works by interfering with the growth of cancer cells, slowing their spread in the body.

  • FOLFOX

    is another chemotherapy regimen that combines fluorouracil, leucovorin, and oxaliplatin. It is used to treat colon cancer by targeting and killing cancer cells, helping to prevent the cancer from returning after surgery.

  • CAPOX

    is a chemotherapy treatment that combines capecitabine and oxaliplatin. Capecitabine is an oral drug that turns into fluorouracil in the body, and oxaliplatin is given intravenously. Together, they work to stop cancer cells from growing and dividing.

  • Trastuzumab

    is a targeted therapy used for treating HER2-positive colon cancer. It works by attaching to the HER2 protein on cancer cells, blocking their growth and survival.

  • Tucatinib

    is another targeted therapy used alongside trastuzumab for HER2-positive colon cancer. It helps to block the signals that promote cancer cell growth, enhancing the effects of trastuzumab.

  • Trifluridine/Tipiracil

    is a combination medication used in the treatment of colon cancer. Trifluridine interferes with the DNA of cancer cells, preventing them from multiplying, while tipiracil helps maintain the levels of trifluridine in the body, making the treatment more effective.

What is already known about the treatment

  • FOLFOXIRI

    This medication is administered intravenously and is a combination of three chemotherapy drugs: fluorouracil, leucovorin, and irinotecan. It is currently used in clinical trials for treating stage III and high-risk stage II resected colon cancer. The main therapeutic indication is to clear circulating tumor DNA (ct-DNA) after surgery. At the molecular level, it works by interfering with DNA synthesis and cell division, leading to cancer cell death. It is classified as an antineoplastic chemotherapy regimen.

  • Trifluridine/Tipiracil

    This medication is taken orally in tablet form. It is being studied in clinical trials for its effectiveness in post-adjuvant treatment of stage III and high-risk stage II colon cancer. The primary therapeutic indication is to reduce ct-DNA levels after initial chemotherapy. Trifluridine incorporates into DNA, disrupting its function, while Tipiracil prevents its breakdown, enhancing its efficacy. It is classified as an antineoplastic agent.

  • Trastuzumab

    Administered intravenously, this medication is currently under investigation in clinical trials for HER2-positive colon cancer. It is primarily indicated for targeting and clearing ct-DNA in patients with specific genetic markers. Trastuzumab binds to the HER2 receptor on cancer cells, inhibiting their growth. It is classified as a monoclonal antibody.

  • Tucatinib

    This medication is taken orally and is being evaluated in clinical trials for HER2-positive colon cancer. It is used to target and reduce ct-DNA levels in patients with specific genetic profiles. Tucatinib works by inhibiting the HER2 protein, which is involved in cancer cell growth. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is part of the digestive tract. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. Stage III colon cancer indicates that the cancer has spread to nearby lymph nodes but not to other parts of the body. High-risk stage II colon cancer refers to cases where the cancer has penetrated the wall of the colon or rectum but has not spread to the lymph nodes, yet certain factors make it more likely to recur. The progression of colon cancer can vary, with some cases remaining localized while others may spread to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515152-20-00Protocol codeERASE-CRCEstimated enrolment477 patientsSponsorFondazione GONO G.I.

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