Ongoing Clinical Trials for Colon Cancer Stage II
There are currently 6 ongoing clinical trials investigating new treatments for colon cancer stage II across Europe. These studies are exploring various approaches including chemotherapy combinations, immunotherapy, targeted therapy, and repurposed medications, aiming to improve outcomes for patients who have undergone surgery for this condition.
Clinical trial locations
- Austria
- 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 (imipramine hydrochloride), a medication traditionally used as an antidepressant, can affect cancer cells in patients with stage II-III disease whose tumors show high levels of a protein called Fascin1.
Main inclusion criteria: Patients must be over 18 years old with a resectable tumor confirmed by biopsy to show overexpression of Fascin1. They must have stage II or stage III colon cancer and provide written informed consent.
Main exclusion criteria: Patients with other types of cancer not specified in the study, those without Fascin1 overexpression, vulnerable populations, and those unable to undergo the required surgical procedures or comply with study requirements are excluded.
Trial focus: The study examines whether Tofranil can cause significant changes in cancer cell characteristics between diagnosis and surgical removal. Researchers will observe changes in tumor structure, immune cell presence around the tumor, levels of tumor DNA in the blood, and Fascin1 protein levels in removed tissue. The treatment period ranges from 2-6 weeks for one group and 3-6 months for patients receiving neoadjuvant therapy.
Investigational drug: Tofranil is administered as a 50 mg coated tablet taken orally. While traditionally a tricyclic antidepressant, it is being explored here for potential anti-cancer properties related to its effects on the epithelial-mesenchymal transition in cancer cells.
Study on Post-Surgery Treatment for Colon Cancer Patients Using Trifluridine, Irinotecan, and Drug Combination
This Italian trial focuses on post-surgery treatments for patients with stage III or high-risk stage II disease, aiming to clear circulating tumor DNA from the blood—a marker indicating 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 3-6 months of treatment with fluoropyrimidine and oxaliplatin, have positive ct-DNA test results after treatment, and have imaging showing no cancer spread. Blood test results must be within normal limits, and tumor tissue must be available for analysis.
Main exclusion criteria: Patients without stage III or high-risk stage II disease, those who haven’t had surgery, those without positive ct-DNA, and vulnerable populations are excluded.
Trial focus: The study compares different treatment combinations in two parts. The first part examines adjuvant therapy comparing FOLFOXIRI against FOLFOX/CAPOX, with a special arm for HER2-positive/RAS wild-type patients using FOLFOX plus Trastuzumab and Tucatinib. The second part focuses on post-adjuvant treatment, comparing Trifluridine/Tipiracil with observation in patients with persistent positive ct-DNA.
Investigational drugs: FOLFOXIRI combines fluorouracil, leucovorin, irinotecan, and oxaliplatin. FOLFOX uses fluorouracil, leucovorin, and oxaliplatin. CAPOX combines capecitabine and oxaliplatin. Trastuzumab is a targeted therapy for HER2-positive cancer. Tucatinib enhances trastuzumab’s effects. Trifluridine/Tipiracil interferes with cancer cell DNA while maintaining effective drug levels.
Study on Adjuvant Therapy with Capecitabine for Stage II Colon and Rectal Cancer Patients with Positive ctDNA After Tumor Removal
This trial, conducted in Germany and Austria, evaluates the effectiveness of additional chemotherapy with capecitabine in patients who have detectable circulating tumor DNA after surgery for stage II disease.
Main inclusion criteria: Patients must have had surgery to remove stage II colon cancer or stage II rectal cancer (if in the upper third of the rectum and not requiring radiation therapy). They must sign informed consent, have known microsatellite or mismatch repair status, and have a confirmed positive ct-DNA result available.
Main exclusion criteria: Patients with conditions other than stage II colon or rectal cancer, those outside the specified age range, and vulnerable populations cannot participate.
Trial focus: The study compares disease-free survival in patients with positive ct-DNA after surgery, with and without additional capecitabine therapy. Participants are randomly assigned to receive either chemotherapy or follow-up without additional treatment. The trial monitors cancer recurrence, spread, or development of new cancers, as well as overall survival and ct-DNA level changes.
Investigational drug: Capecitabine is an oral chemotherapy medication that converts to fluorouracil in the body, helping prevent cancer from returning after surgery. The study will run until June 2029.
Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Resected Colon Cancer
This Belgian trial examines whether daily low-dose aspirin can improve survival rates and prevent cancer recurrence in patients who have undergone surgery for stage II and III disease.
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 surgical removal (R0 resection) within 12 weeks before joining and provide written informed consent.
Main exclusion criteria: Patients who haven’t had surgical removal, those with serious health conditions that might interfere, inability to take the study medication, aspirin allergies, pregnancy or breastfeeding, participation in another trial, bleeding disorders, stomach ulcer history, severe liver or kidney disease, and history of heart disease or stroke.
Trial focus: This double-blind study compares acetylsalicylic acid (aspirin) at 80 mg daily with placebo over five years. The main goal is to determine whether aspirin improves five-year overall survival rates, as well as examining disease-free survival and time to treatment failure.
Investigational drug: Aspirin is taken once daily at 80 mg for five years. While commonly used for pain relief and inflammation, this trial explores its potential benefits in preventing cancer recurrence through inhibition of enzymes that promote inflammation and blood clotting, which may play roles in cancer progression. The study concludes in December 2027.
Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Stage II and III Colon Cancer
This Netherlands-based trial, similar to the Belgian study, investigates daily aspirin for improving outcomes after surgery for stage II and III disease.
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 R0 resection within 12 weeks prior to enrollment and provide written informed consent.
Main exclusion criteria: Patients who haven’t had surgery, those not in stage II or III, inability to take acetylsalicylic acid, those younger than 18, and vulnerable populations are excluded.
Trial focus: This double-blind study randomly assigns participants to receive either 80 mg aspirin daily or placebo for five years. It aims to determine whether aspirin can prevent cancer recurrence and improve five-year overall survival, while also examining disease-free survival and time to treatment failure.
Investigational drug: Aspirin is administered orally once daily at 80 mg for five years. As a non-steroidal anti-inflammatory drug, it is being studied for its potential to inhibit cancer progression by affecting inflammation and blood clotting pathways. The trial continues until the end of 2027.
Study on High-Dose Vitamin C with Ipilimumab and Nivolumab for Patients with Colorectal Cancer
This Italian trial explores combining high-dose intravenous Vitamin C with immunotherapy medications in patients with mismatch repair proficient colorectal cancer before surgery.
Main inclusion criteria: Patients must be at least 18 years old with confirmed colon cancer, willing to avoid pregnancy during the trial, and candidates for surgery based on cancer stage. They must be eligible for surgery to remove the primary cancer and any liver metastasis if present, agree to follow all procedures, have an ECOG performance status less than 2, and provide written consent for both the trial and an observational study called AlfaOmega. Women of childbearing potential need a negative pregnancy test within one week before starting.
Main exclusion criteria: Patients with cancer other than colon cancer, those with pMMR/MSS genetic characteristics, those outside the specified age range, and vulnerable populations cannot participate.
Trial focus: The study examines how well the combination of Ipilimumab, Nivolumab, and high-dose Vitamin C works when given before surgery. Researchers will monitor the pathological response rate and assess whether this combination improves cancer response to treatment before surgical removal. The trial includes regular monitoring visits and concludes in August 2024.
Investigational drugs: Ipilimumab and Nivolumab are immune checkpoint inhibitors administered intravenously that help the immune system recognize and attack cancer cells. Ipilimumab blocks the CTLA-4 protein, while Nivolumab inhibits the PD-1 protein on immune cells. High-dose Vitamin C is given intravenously and is being studied for its potential to enhance the effectiveness of the immunotherapy by supporting immune cell function.
Summary
The six ongoing clinical trials for colon cancer stage II demonstrate diverse therapeutic approaches across Europe. Notably, two trials are testing aspirin for cancer prevention—one in Belgium and one in the Netherlands—both following similar protocols examining whether this widely available medication can prevent recurrence. Germany and Austria are collaborating on a ct-DNA-guided treatment approach using capecitabine, while Italy hosts two distinct studies: one examining complex chemotherapy combinations with targeted therapies, and another exploring immunotherapy enhanced with high-dose Vitamin C. Spain is uniquely investigating imipramine, a repurposed antidepressant, for tumors with specific protein markers.
The trials reflect a shift toward personalized medicine, with several studies using biomarkers like ct-DNA and Fascin1 to guide treatment decisions. Most trials are recruiting patients who have undergone surgery, focusing on preventing recurrence and improving survival. The geographic distribution shows particular research activity in Italy and significant interest in aspirin’s potential benefits across multiple countries. Trial completion dates range from 2024 to 2029, with most extending several years to adequately assess long-term outcomes.
