Not recruiting

Study of Drug Combination Treatment (Capecitabine, Oxaliplatin, Fluorouracil, Irinotecan) Guided by Liquid Biopsy Testing in Patients with Stage III and High-Risk Stage II Colon Cancer

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with colon cancer, specifically those with stage III or high-risk stage II disease who have undergone surgery. The study aims to determine if a special blood test called liquid biopsy can help guide treatment decisions after surgery. This test looks for small pieces of tumor DNA in the blood to monitor if the cancer might return.

The treatment plan includes several anti-cancer medications that work in different ways to fight cancer cells. These medications are capecitabine (taken as tablets by mouth), oxaliplatin (given through a vein as an infusion), fluorouracil (given through a vein), and irinotecan (given through a vein as an infusion). The specific combination of these medications will be determined based on the results of the blood tests.

Throughout the study, participants will have regular blood samples taken to check for signs of cancer using the liquid biopsy test. They will also have routine medical check-ups and imaging tests to monitor their health. The study will track how well patients do over time, particularly focusing on whether they remain cancer-free for two years after their surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Confirmation of stage III or high-risk stage II colon cancer diagnosis through tissue examination
Verification of normal organ functions
Assessment of physical condition using ECOG performance scale (measure of daily living abilities)
Collection of blood sample for liquid biopsy (blood test to detect cancer DNA)
Step 2
Treatment preparation
Review of original tumor tissue sample results
Completion of quality of life questionnaires (QLQ-C30 and CR-29)
For women of childbearing age: pregnancy test and discussion of contraception methods
Step 3
Treatment administration
Receipt of medications through different methods:
Capecitabine: tablets taken by mouth
Oxaliplatin: medicine given through vein infusion
Fluorouracil: medicine given through vein injection or infusion
Irinotecan: medicine given through vein infusion
Step 4
Monitoring period
Regular blood samples for liquid biopsy testing
Assessment of treatment side effects using standard criteria
Regular physical examinations and imaging tests
Completion of quality of life questionnaires at specified intervals
Step 5
Follow-up period
Continued monitoring for up to 2-3 years
Regular assessments to check for signs of disease
Final evaluation at study completion
The study continues until July 2027

Who can join the trial?

9 criteria

Must sign written informed consent for the Pegasus trial
Must be 18 years or older
Must have confirmed stage III or T4N0 stage II colon cancer that is: - Located at least 12 cm from the anal opening - Above the peritoneal reflection (outer lining of the abdomen) - Suitable for surgery
Must have available FFPE tumor tissue (tumor sample preserved in paraffin wax)
Must have blood plasma sample collected before surgery
Must agree to undergo all required liquid biopsies (blood tests to detect cancer cells)
Must have good physical function (ECOG performance status 0-1), meaning able to carry out all or most daily activities
Must have normal organ function
For women who can become pregnant: - Must complete a pregnancy test - Must agree to use reliable birth control methods

Who cannot join the trial?

12 criteria

Age below 18 years or above 75 years
Previous diagnosis of any other type of cancer in the past 5 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Presence of metastatic disease (cancer that has spread to other parts of the body) at diagnosis
Inability to undergo surgery for colon cancer
Presence of microsatellite instability (MSI) in tumor tissue (a specific genetic characteristic of the tumor)
Pregnancy or breastfeeding
Severe mental illness that could affect the ability to provide informed consent
Participation in other clinical trials within 30 days before enrollment
Known allergy or hypersensitivity to study medications
Significant heart, liver, or kidney disease that could interfere with study participation
Inability to provide blood samples for liquid biopsy (a blood test that looks for cancer cells or cancer DNA)
Lack of willingness to follow study procedures and follow-up visits

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Based on the provided trial data, I cannot identify any specific medications or therapies to list, as the source information focuses on a clinical trial studying liquid biopsy (a diagnostic procedure) in colon cancer patients. The trial appears to be an observational study of using blood tests (liquid biopsy) to monitor cancer patients after surgery, rather than testing specific medications or treatments. The trial's focus is on monitoring circulating tumor DNA (ctDNA) in blood samples to guide post-surgical management of colon cancer patients, but no specific medications or therapeutic interventions are mentioned in the provided data. If you have additional information about medications or therapies used in this trial, please provide it for a complete response.

What is already known about the treatment

Since no specific medication names are provided in the source data, I cannot create medication descriptions in the requested format. The provided clinical trial data focuses on liquid biopsy testing for colon cancer patients and does not mention any specific medications or therapeutic agents. The trial appears to be an observational study of post-surgical monitoring rather than a medication trial. If you would like me to create medication descriptions, please provide specific medication names that are being studied or used in clinical trials.

Investigated diseases

Colon cancer – A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably and form tumors. It typically develops slowly over several years, often starting as small, noncancerous clumps of cells called polyps. The cancer usually affects the inner wall of the colon first, and as it grows, it can spread through the different layers of the colon wall. The disease can develop in any part of the colon, which is the final part of the digestive tract. When caught early, the disease is often confined to the colon, but over time it can spread to nearby structures and other organs.