Clinical Trials for Colorectal Cancer Stage II: Current Research and Treatment Approaches
Two clinical trials are currently investigating innovative treatment approaches for patients with Stage II and Stage III colon cancer. These studies focus on personalized treatment strategies guided by blood tests that detect circulating tumor DNA, aiming to improve outcomes for patients who have undergone surgery. The trials are being conducted in several European countries including Italy, Spain, and Germany.
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 clinical trial, known as the SAGITTARIUS trial, investigates a personalized treatment approach for patients with operable Stage III and high-risk Stage II colon cancer. The study aims to determine whether treatment decisions guided by a blood test called circulating tumor DNA (ctDNA) can improve patient outcomes compared to standard chemotherapy.
Main inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of operable stage III or high-risk stage II colon cancer located at least 12 cm from the anal opening. Patients need to have a good performance status, meaning they can carry out most daily activities with little restriction. Normal organ function is required, and the original tumor tissue sample must be available for testing. Women of childbearing age must agree to pregnancy testing and use highly effective birth control methods throughout the study.
Main exclusion criteria: The study does not provide specific exclusion criteria in the source data, but standard requirements include providing written informed consent and meeting all eligibility requirements.
Focus and goal: The trial explores whether using ctDNA blood tests to guide treatment decisions can lead to better outcomes than conventional chemotherapy. After surgery, patients undergo blood testing to check for ctDNA, and based on these results, they are randomly assigned to receive either conventional chemotherapy or a personalized treatment strategy. The study monitors patients’ health and treatment response over time, with a maximum treatment duration of six months and long-term follow-up to assess quality of life and survival rates. The trial is expected to conclude by September 2028.
Investigational drugs: The study uses ctDNA-guided genomic-based targeted treatment, which is a personalized therapy that analyzes information from a patient’s blood to identify specific genetic changes in their tumor. This approach helps doctors choose the most effective treatment for each individual. The trial also compares this approach with conventional adjuvant chemotherapy, which is standard treatment given after surgery to prevent cancer from returning. Various medications are used including Disodium Levofolinate, Temozolomide, Irinotecan, Trastuzumab, Panitumumab, Capecitabine, Calcium Levofolinate, Folinic Acid, Oxaliplatin, Fluorouracil, Pertuzumab, Ipilimumab, and Nivolumab, administered through injections, infusions, or oral capsules.
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, known as the Pegasus trial, focuses on patients with stage III or high-risk stage II colon cancer who have undergone surgery. The trial investigates whether a special blood test called liquid biopsy can help guide treatment decisions after surgery by looking for small pieces of tumor DNA in the blood to monitor if the cancer might return.
Main inclusion criteria: Participants must be 18 years or older with confirmed stage III or T4N0 stage II colon cancer located at least 12 cm from the anal opening and above the peritoneal reflection (outer lining of the abdomen). The cancer must be suitable for surgery, and patients must have their tumor tissue sample available. A blood plasma sample must be collected before surgery, and patients must agree to undergo all required liquid biopsies. Good physical function is essential, meaning the ability to carry out all or most daily activities. Women who can become pregnant must complete pregnancy testing and agree to use reliable birth control methods.
Main exclusion criteria: Patients younger than 18 or older than 75 years are not eligible. Those with any other cancer diagnosis in the past 5 years are excluded, except for adequately treated non-melanoma skin cancer or cervical cancer in situ. Other exclusions include presence of metastatic disease (cancer spread to other organs) at diagnosis, inability to undergo surgery, presence of microsatellite instability in tumor tissue, pregnancy or breastfeeding, severe mental illness affecting consent ability, recent participation in other clinical trials, known allergies to study medications, significant heart, liver, or kidney disease, inability to provide blood samples, or unwillingness to follow study procedures.
Focus and goal: The trial aims to determine if liquid biopsy testing can effectively guide treatment decisions after surgery. Throughout the study, participants have regular blood samples taken to check for signs of cancer using the liquid biopsy test, along with routine medical check-ups and imaging tests. The study tracks how well patients do over time, particularly focusing on whether they remain cancer-free for two years after surgery. The trial continues until July 2027, with ongoing monitoring for up to 2-3 years.
Investigational drugs: The treatment plan includes several anti-cancer medications that work in different ways to fight cancer cells. These include Capecitabine (taken as tablets by mouth), Oxaliplatin (given through a vein as an infusion), Fluorouracil (given through a vein as injection or infusion), and Irinotecan (given through a vein as an infusion). The specific combination of these medications is determined based on the results of the liquid biopsy blood tests.
Summary
Both clinical trials represent innovative approaches to treating high-risk colon cancer by using blood-based testing to personalize treatment decisions. The SAGITTARIUS and Pegasus trials share common features, including focus on Stage III and high-risk Stage II disease, use of ctDNA or liquid biopsy testing to guide treatment, and similar patient eligibility requirements.
A notable observation is the concentration of these trials in Southern European countries, with both studies active in Italy and Spain, and one also conducted in Germany. This geographical distribution may reflect regional expertise in precision medicine approaches for colorectal cancer.
Both trials emphasize personalized treatment strategies rather than a one-size-fits-all approach, representing a shift toward precision medicine in cancer care. The studies utilize blood tests to detect cancer DNA, which is a less invasive monitoring method compared to traditional tissue biopsies. The trials employ various chemotherapy medications and targeted therapies, with treatment decisions guided by individual patient characteristics and test results.
These studies are expected to provide valuable insights into whether personalized, blood-test-guided treatment strategies can improve outcomes for patients with colon cancer compared to standard approaches. Results from these trials may influence future treatment guidelines for patients with high-risk colon cancer following surgery.
