Ongoing Clinical Trials for Colorectal Cancer Stage III
There are currently 3 clinical trials investigating new treatment approaches for Stage III colorectal cancer. These studies are exploring personalized treatment strategies guided by blood tests, as well as immune-based therapies for patients who cannot receive standard chemotherapy. Trials are being conducted in Germany, Italy, and Spain.
Clinical trial locations
- Germany
- Italy
- Study on Colon Cancer Treatment Using Disodium Levofolinate and Drug Combination for Patients with Operable Stage III and High-Risk Stage II Colon Cancer
- 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
- Spain
- Study on Colon Cancer Treatment Using Disodium Levofolinate and Drug Combination for Patients with Operable Stage III and High-Risk Stage II Colon Cancer
- 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
Study on Colon Cancer Treatment Using Disodium Levofolinate and Drug Combination for Patients with Operable Stage III and High-Risk Stage II Colon Cancer
This trial is testing a personalized approach to treatment after surgery. The main goal is to see if using a blood test called ctDNA (circulating tumor DNA) to guide treatment decisions can improve outcomes compared to standard chemotherapy.
Who can join: You may be eligible if you are at least 18 years old with confirmed operable Stage III or high-risk Stage II colon cancer located at least 12 cm from the anal opening. You need to be in good general health (able to carry out light work and daily activities) and have normal organ function. Women who can become pregnant must use reliable birth control and complete a pregnancy test. You must also provide a preserved tumor tissue sample for testing and sign an informed consent form.
Who cannot join: Specific exclusion criteria are not detailed in the available information, but standard restrictions typically apply based on overall health status and ability to tolerate the treatments.
What the trial involves: After surgery, patients have their blood tested for ctDNA. Based on the results, they are randomly assigned to receive either conventional chemotherapy or a personalized treatment plan. The study uses various medications including Disodium Levofolinate, Temozolomide, Irinotecan, Trastuzumab, Panitumumab, Capecitabine, Oxaliplatin, Fluorouracil, Pertuzumab, Ipilimumab, and Nivolumab. These are given in different forms such as injections, infusions, or oral capsules. Treatment lasts for a maximum of six months, with regular follow-ups to monitor health and response.
Investigational approach: The trial compares ctDNA-guided personalized therapy against conventional adjuvant chemotherapy. The personalized approach uses genetic information from blood samples to select the most effective treatment for each individual patient.
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
This study examines whether a blood test called liquid biopsy can help guide treatment decisions after surgery. The test looks for tiny pieces of tumor DNA in the blood to monitor if cancer might return.
Who can join: You must be between 18 and 75 years old with confirmed Stage III or high-risk Stage II colon cancer located at least 12 cm from the anal opening. You need to be in good physical condition (able to carry out most daily activities), have normal organ function, and have a preserved tumor tissue sample available. A blood sample must be collected before surgery, and you must agree to all required blood tests throughout the study. Women who can become pregnant must complete a pregnancy test and use reliable birth control methods.
Who cannot join: You cannot participate if you have had another type of cancer in the past 5 years (except certain skin or cervical cancers that were adequately treated), if the cancer has spread to other parts of the body, or if your tumor shows microsatellite instability. Other exclusions include pregnancy or breastfeeding, severe mental illness, known allergies to study medications, significant heart, liver, or kidney disease, or participation in other clinical trials within 30 days before enrollment.
What the trial involves: The treatment includes a combination of medications: Capecitabine (taken as tablets), Oxaliplatin (given through a vein), Fluorouracil (given through a vein), and Irinotecan (given through a vein). The specific combination depends on blood test results. Throughout the study, regular blood samples are taken to check for signs of cancer, along with routine medical check-ups and imaging tests. The study tracks how well patients do over time, particularly focusing on remaining cancer-free for two years after surgery. Follow-up continues until July 2027.
Investigational approach: The trial uses liquid biopsy testing to monitor circulating tumor DNA and guide post-surgical treatment decisions with chemotherapy combinations.
Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
This trial is specifically for patients with tumors that are MSI-high (microsatellite instability-high) or MMR-deficient (mismatch repair-deficient) who cannot receive or choose not to receive oxaliplatin chemotherapy. The goal is to see if Atezolizumab can improve the chances of staying cancer-free for three years after treatment.
Who can join: You must be at least 18 years old with confirmed Stage III or high-risk Stage II adenocarcinoma of the colon or rectum that is MSI-high or MMR-deficient. Your tumor must have been successfully removed by surgery (or be removable with surgery expected). You need to be able to perform daily activities with some restrictions (ECOG status 0 to 2), have adequate blood counts, liver enzymes, and kidney function, and be unable or unwilling to receive oxaliplatin-based chemotherapy. You must provide written informed consent, agree to follow the study protocol, and if you or your partner can have children, use very effective birth control methods. Certain blood test results must meet specific requirements within 7 days before joining.
Who cannot join: Exclusions include having a different type of cancer than the one being studied, having already received oxaliplatin-based chemotherapy, having an incomplete tumor removal, being pregnant or breastfeeding, having active infections requiring treatment, participating in another clinical trial, having known allergies to the study medication, or having various serious health conditions affecting the heart, lungs, liver, kidneys, immune system, neurological system, or mental health. History of substance abuse, recent live vaccines, recent major surgery, or certain recent medications also prevent participation.
What the trial involves: The treatment uses Atezolizumab, given as an infusion directly into the bloodstream through a vein. The study includes a comparison with a placebo (a substance with no active medication) to evaluate effectiveness. Treatment and monitoring continue for up to 12 months, with regular check-ups to monitor health and cancer status. The study is expected to conclude by February 2025.
Investigational drug: Atezolizumab is an immune checkpoint inhibitor that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. This allows the immune system to better recognize and attack cancer cells.
Summary
Three clinical trials are currently recruiting patients with Stage III colorectal cancer across Germany, Italy, and Spain. Two of these trials focus on personalized treatment approaches guided by blood-based monitoring of circulating tumor DNA, representing a shift toward precision medicine in post-surgical care. Both studies use various chemotherapy combinations and aim to determine whether treatment decisions guided by ctDNA or liquid biopsy testing can improve outcomes compared to standard approaches.
The third trial takes a different approach, focusing specifically on patients with MSI-high or MMR-deficient tumors who cannot receive standard oxaliplatin chemotherapy. This study tests an immune-based therapy called Atezolizumab, which helps the immune system fight cancer cells.
Notably, two trials are being conducted across multiple European countries (Italy and Spain, with one also including Germany), while one trial is limited to Germany. All three studies share a common focus on improving disease-free survival after surgery and offer alternatives to traditional one-size-fits-all chemotherapy approaches. The trials reflect current trends in cancer research: personalized medicine based on molecular testing and immunotherapy for specific patient populations.
