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Study on Chemotherapy with Levoleucovorin, Capecitabine, and Folinic Acid for Patients Aged 70+ After Stage III Colon Cancer Surgery

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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 colon cancer, specifically in patients aged 70 and older who have undergone surgery to remove stage III colon cancer. The study aims to evaluate the effectiveness of different chemotherapy treatments in preventing the return of cancer after surgery. The main goal is to compare how well patients do without the cancer coming back over a period of three years.

The treatments being studied include several medications: Elvorine (levoleucovorin), Xeloda (capecitabine), Folinic acid (as calcium folinate), and Fluorouracil. Elvorine is given as an injection, Xeloda is taken as a tablet, and both Folinic acid and Fluorouracil are administered through an injection or infusion. These medications are used in combination with chemotherapy to help prevent the cancer from returning.

Participants in the study will receive one of the treatment strategies and will be monitored over a period of time to assess their health and any side effects. The study will also look at how well patients tolerate the treatments, how long it takes for the cancer to return, and the overall survival of the patients. Additionally, the study will consider the impact of the treatments on the patients' quality of life and independence. The trial is expected to continue until August 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Introduction to the trial

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate chemotherapy after surgery for stage III colon cancer in patients aged 70 and older.

    The patient will be required to provide informed consent, confirming understanding and agreement to participate in the trial.

  2. Step 2

    Eligibility confirmation

    Eligibility will be confirmed based on criteria such as age (70 or older), recent surgery for stage III colon cancer, and no prior chemotherapy for colon cancer.

    The patient must be deemed fit to receive chemotherapy and complete initial geriatric assessments.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two treatment strategies to compare their effectiveness in preventing cancer recurrence.

  4. Step 4

    Treatment administration

    The patient will receive chemotherapy, which may include medications such as levoleucovorin, capecitabine, folinic acid, and fluorouracil.

    Levoleucovorin and fluorouracil will be administered through intravenous perfusion, while capecitabine will be taken orally as film-coated tablets.

    The specific dosage and frequency will be determined by the medical team based on the patient's condition and response to treatment.

  5. Step 5

    Monitoring and follow-up

    The patient's health and response to treatment will be regularly monitored to assess the effectiveness and tolerance of the chemotherapy.

    Regular follow-up appointments will be scheduled to evaluate the patient's progress and any potential side effects.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until August 31, 2025, with the primary goal of assessing relapse-free survival at three years.

    Upon completion, the patient's overall health, quality of life, and any recurrence of cancer will be evaluated.

Who can join the trial?

11 criteria

  • Must be **70 years old or older**.
  • Male patients must use **effective contraception** during treatment and for at least 6 months after stopping a specific medication called **oxaliplatin**.
  • Must have **signed a consent form** to participate in the study.
  • Must be considered **fit to receive chemotherapy** by a medical team.
  • Must have a **Lee's score** evaluated and sent to the research team. This is a way to assess health status.
  • Must have **stage III upper rectal or colon adenocarcinoma**, which is a type of cancer in the colon or rectum.
  • Must have had a **successful surgery** to remove the primary tumor, known as **resection R0**.
  • Must be able to **start chemotherapy within 12 weeks** after surgery.
  • Must not have had any **prior chemotherapy for colon cancer**.
  • Must complete an **initial geriatric self-questionnaire** and send it to the research team. This is a survey about personal health and well-being.
  • Must complete an **initial geriatric team questionnaire** and send it to the research team. This is a survey filled out by a healthcare team about the patient's health.

Who cannot join the trial?

4 criteria

  • Patients who have not had surgery to remove stage III upper rectal or colon cancer.
  • Patients under the age of 70.
  • Patients with medical conditions other than **colon cancer**.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Adjuvant Chemotherapy is a treatment given after the primary treatment, such as surgery, to lower the risk of the cancer coming back. In this trial, it is used for patients aged 70 and older who have had surgery for stage III colon cancer. The chemotherapy helps to kill any remaining cancer cells and aims to improve the chances of staying cancer-free.

What is already known about the treatment

Capecitabine – Capecitabine is an oral medication used in the treatment of colon cancer, particularly after surgical removal of the tumor. It is currently well-established in medical practice and literature as a chemotherapy agent. The main therapeutic indication is to prevent cancer recurrence in patients who have undergone surgery for stage III colon cancer. Capecitabine works by interfering with the DNA synthesis of cancer cells, ultimately inhibiting their growth and division. It belongs to the pharmacological class of antimetabolites, specifically a prodrug that is converted into 5-fluorouracil in the body.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. It typically 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. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms often include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-518741-21-00Protocol codePRODIGE 34 - ADAGEEstimated enrolment973 patientsSponsorFondation Franc.Cancerologie Digestive

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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).