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Study on Adjuvant Therapy with Capecitabine for Stage II Colon and Rectal Cancer Patients with Positive ctDNA After Tumor Removal

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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 *colon cancer stage II* and *rectal cancer stage II*. The treatment being investigated is a medication called *capecitabine*, which is a type of chemotherapy taken orally. The purpose of the study is to evaluate the effectiveness of additional therapy, known as adjuvant therapy, in patients who have had surgery to remove their primary tumor. The study aims to compare the time patients remain free from cancer, known as disease-free survival, in those who have a specific marker in their blood called *circulating tumor DNA* (ctDNA) after surgery, with and without the additional therapy.

Participants in the study will be randomly assigned to receive either the chemotherapy treatment with *capecitabine* or a follow-up without additional therapy. The study will monitor the participants over time to see if the cancer returns, spreads, or if a new cancer develops. The study will also look at overall survival, which means the length of time patients live after the treatment, regardless of whether the cancer comes back. The study will continue to collect data on the participants' health and any side effects they may experience from the treatment.

The trial will also explore other factors, such as the level of ctDNA before any recurrence of cancer and how it changes during or after chemotherapy. This information will help researchers understand the relationship between ctDNA levels and the risk of cancer returning or spreading. The study is expected to provide valuable insights into the best treatment approaches for patients with stage II colon and rectal cancer.

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

    Joining the study

    Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

    Eligibility is confirmed based on specific criteria, including having stage II colon or rectal cancer that has been surgically removed.

  2. Step 2

    Screening phase

    A screening process determines the presence of circulating tumor DNA (ctDNA) in the blood. This helps decide the next steps in the study.

  3. Step 3

    Randomization

    Participants with positive ctDNA results are randomly assigned to either receive adjuvant therapy or to be in a follow-up group without additional treatment.

    Participants with negative ctDNA results are assigned to a follow-up group.

  4. Step 4

    Adjuvant therapy

    For those receiving adjuvant therapy, the medication used is capecitabine, taken orally.

    The dosage and frequency of capecitabine are determined by the study protocol and medical team.

  5. Step 5

    Follow-up

    Regular follow-up appointments are scheduled to monitor health status and detect any recurrence of cancer.

    The follow-up period includes assessments of disease-free survival and overall survival.

  6. Step 6

    End of study

    The study is expected to conclude by June 30, 2029.

    Final evaluations will be conducted to assess the outcomes of the study, including survival rates and any adverse events experienced during the trial.

Who can join the trial?

6 criteria

  • The patient must have had surgery to remove **colon cancer stage II** or **rectal cancer stage II**. If the rectal cancer is located in the upper third of the rectum and does not require radiation therapy, it should be treated like colon cancer.
  • The patient must sign a document called **informed consent** to agree to participate in the screening and the randomized phase of the study. This means they understand the study and agree to take part.
  • The patient must have a known **microsatellite** or **mismatch repair status**. This refers to specific characteristics of the cancer cells that can affect how the cancer behaves and responds to treatment.
  • The patient must have a confirmed **ctDNA result** available. **ctDNA** stands for circulating tumor DNA, which is a type of DNA that comes from cancer cells and can be found in the blood.
  • The study is open to both male and female patients.
  • The study is not specifically for vulnerable populations, meaning it is not designed for groups that might need special protection or care.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than **colon cancer stage II** or **rectal cancer stage II** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.
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Investigated drugs

Adjuvant Therapy is a treatment given in addition to the primary or main therapy to maximize its effectiveness. In this trial, it is used for patients with colon cancer to help prevent the cancer from returning after the primary tumor has been surgically removed. The goal is to improve disease-free survival in patients who have detectable circulating tumor DNA (ctDNA) after surgery.

What is already known about the treatment

Circulating Tumor DNA Test – This test is administered through a blood sample, where circulating tumor DNA (ctDNA) is analyzed to guide treatment decisions. It is currently being evaluated in clinical trials for its effectiveness in determining the need for adjuvant therapy in patients with stage II colon and rectal cancer. The main therapeutic indication is to improve disease-free survival by identifying patients who may benefit from additional treatment after surgery. The mechanism involves detecting small fragments of DNA released by cancer cells into the bloodstream, which can indicate the presence of residual disease. This test falls under the category of diagnostic tools in oncology.

Investigated diseases

  • Colon Cancer Stage II

    This is a type of cancer that begins in the colon, which is part of the large intestine. In stage II, the cancer has grown through the wall of the colon but has not spread to nearby lymph nodes or distant sites. The progression involves the cancer cells invading deeper layers of the colon wall. It may cause symptoms like changes in bowel habits, abdominal pain, or blood in the stool. The disease can progress if cancer cells continue to grow and potentially spread to other parts of the body. Monitoring and management are crucial to prevent further advancement.

  • Rectal Cancer Stage II

    This cancer originates in the rectum, the last several inches of the large intestine. At stage II, the cancer has penetrated the rectal wall but has not reached the lymph nodes or distant organs. The disease progresses as the tumor grows deeper into the rectal layers. Symptoms might include rectal bleeding, changes in bowel habits, or discomfort. If unchecked, the cancer can advance and potentially spread beyond the rectum. Regular monitoring is essential to manage the disease's progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506715-18-00Protocol codeTUD-CIRC01-071Estimated enrolment140 patientsSponsorTechnische Universitaet Dresden

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