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Study of drug combination (capecitabine, fluorouracil, oxaliplatin, calcium folinate) to prevent cancer recurrence in patients with detectable ctDNA after rectal cancer surgery

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 patients with rectal cancer who show signs of tumor DNA in their blood after surgery. The study aims to determine if additional treatment after surgery can help prevent the cancer from returning. The treatment being studied combines several anti-cancer medications: capecitabine (taken by mouth), fluorouracil and oxaliplatin (given through a vein), along with calcium folinate which helps enhance the effectiveness of fluorouracil.

The treatment involves a combination of medications commonly used to treat cancer, known as chemotherapy. These drugs work together to destroy any remaining cancer cells that might be present in the body after surgery. The treatment will be given over several months to determine if it can improve the time patients remain free from cancer returning.

During the study, patients will receive the chemotherapy treatment and have regular check-ups to monitor their health. Blood samples will be taken to check for signs of cancer DNA, which can indicate whether the treatment is working. The study will track how long patients remain cancer-free and their overall survival, while also monitoring their quality of life during and after treatment.

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

    Initial screening and confirmation

    Your eligibility for the study will be verified based on specific criteria, including being at least 18 years old and having a WHO performance score of 0-1

    Confirmation of rectal cancer diagnosis through histological examination is required

    A blood test will be performed to check for detectable ctDNA (circulating tumor DNA) in your post-surgery blood sample

  2. Step 2

    Treatment assignment

    You will be assigned to receive adjuvant chemotherapy treatment

    The treatment will consist of either CAPOX or FOLFOX chemotherapy regimen

  3. Step 3

    Chemotherapy administration - CAPOX option

    Capecitabine will be taken by mouth

    Oxaliplatin will be administered through intravenous infusion

  4. Step 4

    Chemotherapy administration - FOLFOX option

    Fluorouracil will be administered through intravenous infusion

    Calcium folinate will be administered through intravenous infusion

    Oxaliplatin will be administered through intravenous infusion

  5. Step 5

    Follow-up period

    Regular blood samples will be collected to monitor ctDNA levels

    Your overall health status and quality of life will be assessed

    Imaging tests will be performed to monitor for any disease recurrence

    The study will continue until September 2030

Who can join the trial?

11 criteria

  • Must be 18 years or older
  • Must have a WHO performance score of 0-1 (ability to perform daily activities with minimal limitations)
  • Must provide signed informed consent for participation in the PLCRC study, including agreement for additional blood samples and future research
  • Must provide separate informed consent for the REACT trial
  • Must have confirmed rectal cancer through tissue examination, with either:
    • Previous treatment with radiation therapy (with or without chemotherapy), or
    • Cancer that has grown through the bowel wall (T4), or
    • Cancer that has spread to lymph nodes (N+)
    • Must be considered suitable by their doctor to receive combination chemotherapy treatment (either CAPOX or FOLFOX regimens)
    • Must be able to understand and read the Dutch language
    • Must have detectable circulating tumor DNA (ctDNA) in blood sample taken after surgery
    • Must be mentally capable of understanding and following study procedures

Who cannot join the trial?

14 criteria

  • History of other cancers within the past 5 years (except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Previous treatment with chemotherapy (treatment using drugs to destroy cancer cells) for rectal cancer
  • Serious heart conditions including heart failure (when heart cannot pump blood effectively) or recent heart attack within 6 months
  • Severe kidney or liver disease that could affect treatment
  • Active infection requiring systemic treatment (medication that affects the whole body)
  • Pregnant or breastfeeding women
  • Known allergic reactions to the study medications
  • Participation in another clinical trial within the past 30 days
  • Mental conditions that could interfere with following study procedures
  • Inability to give informed consent
  • Metastatic disease (cancer that has spread to other parts of the body)
  • Blood disorders that could make chemotherapy unsafe
  • Uncontrolled diabetes (high blood sugar levels)
  • Major surgery planned during the study period (except for the planned cancer surgery)
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Investigated drugs

  • Calcium folinate

    is given by intravenous infusion. It is used to help protect normal cells and to boost the action of other chemotherapy medicines. In this study it is part of the combination treatment given after surgery to try to lower the chance that the cancer returns.

  • Oxaliplatin

    is an intravenous chemotherapy drug that works by damaging the DNA of cancer cells, which stops them from growing and dividing. In the trial it is given after the operation as a key component of the adjuvant chemotherapy regimen aimed at preventing cancer recurrence.

  • Capecitabine

    is an oral chemotherapy medication that the body changes into an active form that interferes with cancer cell growth. Patients take it by mouth at home, and in this study it is used after surgery to help eliminate any remaining cancer cells and improve disease‑free survival.

  • Fluorouracil

    is an intravenous chemotherapy drug that blocks the production of DNA and RNA in cancer cells, slowing their growth. In the trial it is combined with the other drugs as part of the postoperative chemotherapy plan to reduce the risk of the cancer coming back.

What is already known about the treatment

  • Calcium folinate

    Calcium folinate is supplied as a sterile solution for injection or infusion and is given intravenously. It is an approved medicine that has been used for decades in cancer therapy and to lessen toxicity from other drugs. It is mainly used together with fluorouracil in the treatment of colorectal (including rectal) cancer and to rescue normal cells from methotrexate side effects. It works by providing a form of folate that helps cells make DNA and also boosts the action of fluorouracil, placing it in the antimetabolite (folate rescue) class.

  • Oxaliplatin

    Oxaliplatin is provided as a powder that is reconstituted into a solution for injection and is administered intravenously. It is a widely accepted chemotherapy drug that is listed in current medical guidelines for colorectal cancer. Its main use is as part of combination regimens for treating rectal and other colorectal cancers after surgery. It kills cancer cells by forming platinum‑based links in DNA that prevent the DNA from copying correctly, classifying it as a platinum‑based alkylating agent.

  • Capecitabine

    Capecitabine comes as oral tablets that patients swallow with water. It is an approved, oral chemotherapy drug that is commonly used in modern colorectal cancer treatment. It is mainly prescribed for rectal cancer patients who need chemotherapy after surgery, either alone or with other drugs. Inside the body it is changed into fluorouracil, which blocks an enzyme needed for DNA building, making it an antimetabolite pro‑drug.

  • Fluorouracil

    Fluorouracil is supplied as a solution for injection or infusion and is given intravenously. It is a classic, well‑established chemotherapy agent that has been in clinical use for many years. It is primarily used to treat colorectal (including rectal) cancer, often together with other drugs such as oxaliplatin or calcium folinate. It works by mimicking a building block of DNA and stopping the enzyme that makes DNA, thereby halting cancer cell growth; it belongs to the antimetabolite class.

Investigated diseases

Rectal Cancer - A disease that begins when cells in the rectum (the last part of the large intestine) start to grow out of control. It typically develops slowly from polyps, which are small growths on the inner lining of the rectum. The disease usually affects the innermost layer of the rectum first, and over time can grow through the rectal wall. Rectal cancer can spread to nearby tissues and lymph nodes, and may eventually reach other parts of the body. The condition often develops without early warning signs, though it may cause changes in bowel habits and rectal bleeding as it progresses.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517700-12-00Estimated enrolment103 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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