In short
There are currently 6 ongoing clinical trials exploring different treatment approaches for patients with Stage III colon cancer. These trials are investigating medications ranging from repurposed drugs like imipramine and aspirin to combination chemotherapy regimens and immunotherapy treatments. The studies are taking place across multiple European countries including Spain, Italy, Belgium, the Netherlands, and Germany.
Clinical trial locations
- Belgium
- Germany
- Italy
- Netherlands
- Spain
Study on the Effects of Imipramine in Patients with Colon, Rectal, or Breast Cancer Over-Expressing Fascin1
This Spanish trial is investigating whether Tofranil, which contains the active ingredient imipramine hydrochloride, can affect cancer cells in patients with Stage II-III colon cancer that shows high levels of a protein called Fascin1. Imipramine is traditionally used as an antidepressant, but researchers are exploring whether it might have anti-cancer properties.
Main inclusion criteria: Patients must be over 18 years old with a confirmed diagnosis of colon cancer showing overexpression of Fascin1. The tumor must be resectable, meaning it can be removed by surgery. Participants must provide written informed consent.
Main exclusion criteria: Patients with cancer types not specified in the study, those without Fascin1 overexpression, patients outside the specified age range, vulnerable populations, and those unable to undergo required surgical procedures are excluded. Patients with medical conditions that would make participation unsafe are also excluded.
Treatment focus: The study examines whether Tofranil can cause significant changes in cancer cells between diagnosis and surgical removal. Researchers will observe changes in tumor structure, immune cell presence around the tumor, levels of tumor DNA in blood, and Fascin1 protein levels in removed tissue. The treatment period ranges from 2-6 weeks for some patients and 3-6 months for others receiving neoadjuvant treatment.
Investigational drug: Tofranil is administered as a 50 mg coated tablet taken orally.
Study on Post-Surgery Treatment for Colon Cancer Patients Using Trifluridine, Irinotecan, and Drug Combination
This Italian trial explores different treatment combinations for patients who have undergone surgery for Stage III or high-risk Stage II colon cancer. The study aims to find the most effective strategy to clear circulating tumor DNA from the blood, which indicates the presence of cancer cells.
Main inclusion criteria: Patients must be 18 years or older with confirmed Stage III or high-risk Stage II colon cancer. They must have completed fluoropyrimidine and oxaliplatin treatment for 3-6 months. Recent scans must show no cancer spread. Blood tests must show positive circulating tumor DNA. Patients must have adequate blood counts, liver and kidney function, and tumor tissue available for analysis. Women of childbearing age must have a negative pregnancy test.
Main exclusion criteria: Patients without Stage III or high-risk Stage II diagnosis, those who haven't had surgery, patients without positive circulating tumor DNA after surgery, those outside the age range, and patients unable to receive the study treatments are excluded.
Treatment focus: The study has two parts. The first examines adjuvant therapy after surgery, comparing FOLFOXIRI against FOLFOX/CAPOX combinations. For patients with HER2-positive/RAS wild-type cancer, it compares FOLFOX plus Trastuzumab and Tucatinib. The second part focuses on post-adjuvant treatment, examining Trifluridine/Tipiracil versus observation in patients with positive circulating tumor DNA after initial therapy.
Investigational drugs: The trial uses several medications: FOLFOXIRI (fluorouracil, leucovorin, irinotecan, and oxaliplatin), FOLFOX (fluorouracil, leucovorin, and oxaliplatin), CAPOX (capecitabine and oxaliplatin), Trastuzumab (a targeted therapy for HER2-positive cancer), Tucatinib (another HER2 inhibitor), and Trifluridine/Tipiracil (which interferes with cancer cell DNA).
Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Resected Colon Cancer
This Belgian trial investigates whether daily aspirin can improve survival rates and prevent cancer recurrence in patients who have had surgery for Stage II and III colon cancer.
Main inclusion criteria: Patients must be 45 years or older with confirmed adenocarcinoma of the colon at specific TNM stages (pT3-4; N0-2 and M0, or pT1-2 and N1-2), corresponding to UICC Stage II and III. They must have had curative surgery with complete cancer removal within 12 weeks before joining. Written informed consent is required.
Main exclusion criteria: Patients who haven't had surgical removal, those with serious health conditions interfering with the study, patients unable to take aspirin or allergic to it, pregnant or breastfeeding women, participants in other trials, and those with bleeding disorders, stomach ulcers, severe liver or kidney disease, or history of heart disease or stroke are excluded.
Treatment focus: The double-blind study compares 80 mg of aspirin daily against placebo for five years. Researchers monitor whether aspirin prevents cancer recurrence and improves overall survival. Regular follow-ups track health status and cancer recurrence.
Investigational drug: Aspirin is taken as an 80 mg tablet once daily for five years.
Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Stage II and III Colon Cancer
This Dutch trial, similar to the Belgian study, examines aspirin's potential to prevent cancer recurrence and improve survival in patients with surgically removed Stage II and III colon cancer.
Main inclusion criteria: Patients must be 45 years or older with confirmed adenocarcinoma of the colon at Stage II or III (determined by TNM staging). They must have had successful cancer removal surgery within the last 12 weeks. Written informed consent is required.
Main exclusion criteria: Patients who haven't had surgery, those not in Stage II or III, patients unable to take aspirin, those younger than 18 years, and vulnerable populations are excluded.
Treatment focus: This double-blind study compares 80 mg of daily aspirin against placebo to determine effects on five-year overall survival. The study also examines disease-free survival and time to treatment failure. The trial continues until the end of 2027.
Investigational drug: Aspirin is administered orally as a daily 80 mg pill for five years.
Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
This German trial studies atezolizumab for patients with high-risk Stage II or Stage III colorectal cancer who have MSI-high or MMR-deficient tumors and cannot receive or choose not to receive oxaliplatin chemotherapy.
Main inclusion criteria: Patients must be 18 years or older with confirmed adenocarcinoma of the colon or rectum at high-risk Stage II or Stage III. The tumor must be MSI-high or MMR-deficient. Patients must have had successful or mostly successful surgery. They must have ECOG status of 0 to 2 and be unable or unwilling to receive oxaliplatin-based treatment. Adequate blood counts, liver enzymes, and kidney function are required. Blood test results for INR and PTT must be within acceptable ranges. Women of childbearing age and men with partners who can have children must agree to use effective birth control.
Main exclusion criteria: Patients with different cancer types, those who already received oxaliplatin chemotherapy, patients whose tumor wasn't completely removed, those unwilling to follow procedures, pregnant or breastfeeding women, participants in other trials, patients with allergies to the study medication, active infections, or certain heart, lung, liver, kidney, immune system, neurological, or psychiatric conditions are excluded. Patients with substance abuse history or who received live vaccines or major surgery within certain timeframes are also excluded.
Treatment focus: The study aims to improve disease-free survival at three years in patients with specific tumor characteristics who cannot use standard chemotherapy. Treatment lasts up to 12 months with regular monitoring for side effects and disease status.
Investigational drug: Atezolizumab is given as an intravenous infusion. It works by blocking PD-L1 protein, helping the immune system recognize and attack cancer cells.
Study on High-Dose Vitamin C with Ipilimumab and Nivolumab for Patients with Colorectal Cancer
This Italian trial investigates a combination treatment of Ipilimumab, Nivolumab, and high-dose Vitamin C given before surgery to patients with mismatch repair proficient colorectal cancer.
Main inclusion criteria: Patients must be at least 18 years old with confirmed colon cancer diagnosis. They must be surgery candidates based on cancer stage, including cases where cancer has spread to the liver but remains surgically removable. Patients must agree to avoid pregnancy using effective birth control, follow all study procedures, and be available for the entire study duration. They must have ECOG performance status less than 2. Women of childbearing potential must have a negative pregnancy test within one week before starting. Written consent for both the study and an observational study called AlfaOmega is required.
Main exclusion criteria: Patients with cancer types other than colon cancer, those with pMMR/MSS genetic characteristics, patients outside the specified age range, and vulnerable populations are excluded.
Treatment focus: The study examines whether the combination of two immune checkpoint inhibitors with high-dose Vitamin C can improve cancer response before surgery. Ipilimumab and Nivolumab help the immune system target cancer cells, while high-dose Vitamin C may boost their effectiveness. Researchers monitor pathological response and overall treatment effectiveness.
Investigational drugs: Ipilimumab and Nivolumab are administered through intravenous infusion. High-dose Vitamin C is also given as an infusion. All three medications are delivered directly into the bloodstream.
Summary
The six ongoing clinical trials for Stage III colon cancer reflect diverse research approaches across Europe. Italy hosts two trials, while Belgium, Germany, the Netherlands, and Spain each conduct one study. The trials explore varied treatment strategies, from repurposing established medications like aspirin and imipramine to testing advanced immunotherapy combinations.
Two trials focus on aspirin's potential to prevent recurrence and improve survival in Belgium and the Netherlands, both using identical 80 mg daily doses over five years. The Italian studies examine more complex interventions: one investigates circulating tumor DNA-guided treatment with multiple chemotherapy combinations, while another explores immunotherapy with high-dose Vitamin C before surgery.
The German trial addresses patients unable to receive standard oxaliplatin chemotherapy, offering immunotherapy with atezolizumab for those with specific tumor characteristics. The Spanish study takes an innovative approach by testing imipramine, traditionally an antidepressant, for its potential anti-cancer properties in tumors overexpressing Fascin1.
These trials demonstrate the evolving landscape of colon cancer treatment, moving beyond conventional chemotherapy to include immunotherapy, targeted therapies, and repurposed drugs. The focus on biomarkers like circulating tumor DNA, MSI status, and Fascin1 expression reflects increasingly personalized treatment approaches.
