Colon cancer Trials in Disease

A study of peginterferon alfa-2a to improve immune system function during colon cancer surgery

This trial investigates the effects of peginterferon alfa-2a on immune system function in patients undergoing surgery for colon cancer. The study focuses on maintaining immune cell activity during and after the surgical procedure, as surgery typically causes temporary weakening of the immune system.

Inclusion criteria: Patients must be 18 years or older with a diagnosis of pMMR colonic adenocarcinoma, a common type with normal DNA repair mechanisms. They must be scheduled for laparoscopic hemicolectomy and have an ASA classification of I-III, indicating good to moderate health status before surgery.

Exclusion criteria: The trial excludes patients under 18 or over 65 years, those with known allergies to study medications, active infections, pregnancy or breastfeeding, severe organ disease, autoimmune conditions, blood disorders, or those unable to follow study procedures.

Focus: The study examines how peginterferon alfa-2a affects various types of immune cells in both blood and tumor tissue. The medication is given before and after surgery through subcutaneous injection at specific doses for up to 14 days. Researchers will compare immune responses between patients receiving the medication and those receiving a placebo.

Investigational drug: Peginterferon alfa-2a is used in low doses to prevent perioperative immune suppression. This interferon protein helps maintain the number and function of white blood cells that fight disease, particularly during the vulnerable period around surgery.

Study of CAPOX or FOLFOX chemotherapy before surgery in patients with obstructive colon cancer treated with colostomy

This trial examines whether giving chemotherapy before surgery can improve outcomes for patients with obstructive cancer who initially received a temporary colostomy to relieve the blockage. The study compares this approach to the standard practice of giving chemotherapy after surgery.

Inclusion criteria: Patients must be at least 18 years old with confirmed adenocarcinoma located at least 10 cm from the anal opening. They must have good physical performance status, adequate blood cell counts, and normal liver and kidney function. Previous treatment with a defunctioning stoma for bowel obstruction is required, and the cancer must not have spread to other body parts.

Exclusion criteria: The study excludes patients under 18 or over 75, those with distant metastases, previous chemotherapy or radiation for colorectal cancer, severe heart or kidney conditions, active infections, pregnancy or breastfeeding, and those unable to follow study procedures.

Focus: The trial tests two chemotherapy combinations - CAPOX (capecitabine and oxaliplatin) and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) - given before the main surgery. The primary goal is to assess treatment completion rates and monitor recovery after surgery.

Investigational drugs: Both CAPOX and FOLFOX are standard chemotherapy combinations that work by stopping or slowing cancer cell growth. CAPOX is partly oral and partly intravenous, while FOLFOX is entirely given through intravenous infusion.

Study of Dostarlimab and Drug Combination for Patients with Untreated Resectable Colon Cancer

This multi-country trial evaluates dostarlimab for patients with untreated T4N0 or Stage III colon cancer showing dMMR or MSI-H genetic characteristics. The study compares dostarlimab treatment with standard care to determine effectiveness before and after surgery.

Inclusion criteria: Participants must be at least 18 years old with ECOG performance status of 0 or 1 and adequate organ function. They must have untreated, resectable colon adenocarcinoma at clinical T4N0 or Stage III with dMMR or MSI-H status confirmed by testing. A tumor tissue sample and signed informed consent are required.

Exclusion criteria: Patients who have already received treatment for their cancer, those with cancer that cannot be surgically removed, or those with other serious health conditions are excluded. Pregnant or breastfeeding women, those with allergies to study medications, and patients unable to follow study procedures cannot participate.

Focus: The study monitors how effectively dostarlimab works before and after surgery compared to standard treatments. Regular assessments track cancer response, side effects, and health outcomes through radiological evaluations and pathological examinations.

Investigational drug: Dostarlimab is an immune checkpoint inhibitor that works by blocking a protein that helps cancer cells evade the immune system, allowing the body to better attack cancer cells. It is administered intravenously as a 500 mg infusion.

Study of Dostarlimab for Patients with Untreated Stage III Resectable Colon Cancer

This trial studies the molecular changes that occur when patients with untreated pMMR/MSS colon cancer receive dostarlimab before surgery. The research aims to create a database of these changes for future research on this subtype of cancer.

Inclusion criteria: Patients must have untreated pMMR/MSS colon adenocarcinoma that is resectable and clinically staged as cT3-4, cN0-2, cM0, or stage III. They must be at least 18 years old with ECOG performance status 0-1 and adequate bone marrow, kidney, and liver function. Tumor and normal tissue samples from biopsies must be available.

Exclusion criteria: Patients with any cancer type other than pMMR/MSS resectable colon cancer, those who have received previous treatment, or those with health conditions that might interfere with the study are excluded. Vulnerable populations unable to give informed consent cannot participate.

Focus: The study examines molecular and biological changes in cancer tissue and blood samples during neoadjuvant dostarlimab treatment. Regular monitoring assesses treatment response, side effects, and long-term outcomes including disease-free survival and overall survival.

Investigational drug: Dostarlimab is administered intravenously at 500 mg. It works by inhibiting the PD-1 protein on immune cells, helping the immune system recognize and attack cancer cells more effectively.

Study on Pre-Operative Chemotherapy with Disodium Folinate, Oxaliplatin, and Fluorouracil for Patients with Advanced Resectable Colon Cancer

This trial compares pre-operative chemotherapy with the standard approach of surgery followed by treatment for patients with advanced but resectable colon cancer at stages T3-4 and/or with positive lymph nodes.

Inclusion criteria: Patients must be at least 18 years old with confirmed adenocarcinoma of the colon or upper rectum showing mismatch-repair proficiency. They must have stage T3 or T4 cancer and/or nodal positivity on CT or MRI scan, with no distant metastases. Adequate bone marrow, liver, and kidney function are required, along with WHO performance status 0-2.

Exclusion criteria: Patients with distant metastases are excluded from this study focused on locally advanced but resectable disease.

Focus: The study evaluates whether starting chemotherapy before surgery can improve three-year disease-free survival compared to surgery followed by adjuvant chemotherapy. Various combinations of medications including disodium folinate, oxaliplatin, fluorouracil, irinotecan, and capecitabine are tested.

Investigational drugs: The trial uses several chemotherapy medications given as solutions for infusion or oral tablets. These drugs work by interfering with DNA synthesis in cancer cells, preventing their growth and division.

Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

This expanded access trial provides selpercatinib to patients with advanced cancers showing RET gene alterations who are not eligible for other ongoing trials. While colon cancer is included, the study encompasses multiple cancer types.

Inclusion criteria: Patients must be at least 18 years old with locally advanced or metastatic tumors showing RET alteration. They must have progressed on, be intolerant to, or have no standard therapy available. Adequate blood, kidney, and liver function are required, along with inability to participate in other selpercatinib trials due to clinical, geographic, or financial constraints.

Exclusion criteria: Patients younger than 18, those without RET alteration, pregnant or breastfeeding women, and those with other medical conditions that might interfere with the study are excluded.

Focus: This expanded access program provides treatment rather than collecting research data. Patients receive selpercatinib orally, with monitoring for safety and effectiveness. The program aims to provide treatment options for patients with limited alternatives.

Investigational drug: Selpercatinib is a targeted therapy that works by inhibiting the RET protein involved in cell growth and division. By blocking this protein, it helps slow or stop cancer cell growth in tumors with RET alterations.

Study on the Effectiveness of Autogene Cevumeran in Patients with ctDNA Positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

This trial evaluates RO7198457 (autogene cevumeran) in patients who have detectable circulating tumor DNA after surgery for stage II high-risk or stage III cancer, indicating higher recurrence risk. The study compares active treatment with watchful waiting.

Inclusion criteria: Patients must be at least 18 years old with resected stage II high-risk or stage III colorectal cancer and detectable ctDNA before starting chemotherapy. They must have received standard chemotherapy for at least 3 months starting within 8 weeks after surgery. At least 5 tumor neoantigens must be identified, and adequate organ function is required.

Exclusion criteria: Patients with medical conditions other than the specified cancer stages, those not pretreated with chemotherapy, and those outside the study age range are excluded.

Focus: The trial assesses whether RO7198457 can improve disease-free survival compared to watchful waiting in ctDNA-positive patients. Regular monitoring includes ctDNA status checks approximately every three months and evaluation of treatment-emergent adverse events.

Investigational drug: RO7198457 is an investigational medication administered as an intravenous injection. It targets specific molecular pathways involved in cancer cell growth to prevent recurrence in high-risk patients.

A study evaluating the effects of intravenous lidocaine on pain control and recovery after colon cancer surgery

This study examines whether giving lidocaine intravenously during and after laparoscopic surgery can reduce pain medication needs and improve recovery in patients undergoing surgery for colon cancer.

Inclusion criteria: Patients must be between 18 and 80 years old with planned laparoscopic colon surgery that includes anastomosis. They must have an ASA score of 3 or less, indicating reasonable anesthesia safety, and be able to understand study procedures and provide informed consent.

Exclusion criteria: The study excludes patients with known allergies to lidocaine or similar medications, severe heart conditions, severe liver disease, pregnancy or breastfeeding, chronic pain requiring regular opioids, and emergency surgeries.

Focus: The primary goal is determining whether lidocaine infusion reduces opioid medication requirements in the first 24 hours after surgery. Secondary outcomes include time to normal bowel function recovery and overall patient recovery.

Investigational drug: Lidocaine is a local anesthetic given through intravenous infusion during and after surgery. It works by blocking nerve signals that transmit pain, potentially reducing the need for opioid pain medications and improving recovery outcomes.

Study of 18F-FAPI-74 PET/CT Imaging for Detection of Lymph Node Metastases in Patients with Colon Cancer

This imaging study evaluates a new diagnostic technique using [18F]FAPI-74 radiotracer with PET/CT scanning to detect cancer spread to nearby lymph nodes in patients at different stages of diagnosis and treatment.

Inclusion criteria: Patients must be adults (18 or older) with primary colon cancer and suspected lymph node spread on CT scan before surgery, potentially curable metastatic disease, or suspected recurrence during follow-up with elevated CEA levels. WHO performance score must be between 0-2, and patients must provide signed informed consent.

Exclusion criteria: Patients under 18, those with previous cancer treatment, known allergies to imaging agents, pregnant or breastfeeding women, other active cancers, inability to lie still for scanning, severe kidney dysfunction, metal implants interfering with imaging, and those unable to provide informed consent are excluded.

Focus: The study evaluates how accurately [18F]FAPI-74 PET/CT can detect lymph node metastases compared to standard imaging methods. Patients receive a single injection of the radiotracer followed by PET/CT scanning.

Investigational tool: 18F-FAPI-74 is a radioactive imaging agent that binds to proteins commonly found in cancer cells, particularly fibroblast activation proteins. This helps create detailed images showing potential cancer spread to lymph nodes.

Study on Aspirin's Effect on Recurrence and Survival in Patients with Non-Metastatic Breast, Colon, Rectal, Stomach, Esophageal, and Prostate Cancer

This large study examines whether regular aspirin use after standard cancer treatment can prevent recurrence and improve survival in patients with various non-metastatic solid tumors, including colon cancer. The double-blind design ensures unbiased results.

Inclusion criteria: Patients must have completed standard therapy for breast, colon, rectal, stomach, esophageal, or prostate cancer with no signs of disease spread. They must have WHO performance status 0-2 and provide written informed consent. Specific criteria apply depending on cancer type, including surgery completion and certain test results.

Exclusion criteria: Patients with metastatic cancer, those unable to take aspirin due to allergies or medical reasons, those who haven't completed standard therapy, pregnant or breastfeeding women, and those participating in conflicting trials are excluded.

Focus: Participants receive either 100 mg or 300 mg daily aspirin or matching placebo in gastro-resistant tablets for up to 60 months. The study monitors disease-free survival, overall survival, and adverse events including bleeding and vascular complications.

Investigational drug: Aspirin is studied for its potential to prevent cancer recurrence by inhibiting cyclooxygenase enzymes involved in inflammation and cell growth. It is taken daily as a gastro-resistant tablet to minimize stomach irritation.

Summary

The 24 ongoing clinical trials for colon cancer represent diverse approaches to improving treatment outcomes across different disease stages. A notable concentration of trials is taking place in France, which hosts 11 of the 24 studies, followed by Spain with 6 trials. This geographic distribution suggests strong research infrastructure and patient recruitment capabilities in these countries.

Several key treatment approaches are being investigated. Immunotherapy trials, particularly those studying dostarlimab and pembrolizumab, show significant promise for patients with specific genetic markers like dMMR/MSI-H. Multiple trials examine chemotherapy combinations, with oxaliplatin appearing in numerous studies combined with various other agents such as fluorouracil, capecitabine, and irinotecan. The FOLFOX and CAPOX regimens are being tested in different clinical scenarios, from neoadjuvant to adjuvant settings.

An important trend is the personalized medicine approach, with several trials focusing on specific genetic mutations such as BRAF V600E, PI3K mutations, and RET alterations. The use of circulating tumor DNA (ctDNA) as a biomarker for treatment decisions appears in multiple studies, reflecting the growing importance of molecular monitoring in cancer management.

The trials address various treatment timing strategies - neoadjuvant therapy (before surgery), adjuvant therapy (after surgery), and perioperative approaches. Several studies specifically target high-risk populations, including elderly patients aged 70 and above, and those with locally advanced or high-risk stage II and III disease.

Innovative approaches include trials examining aspirin for cancer prevention, lidocaine for perioperative care, high-dose vitamin C combined with immunotherapy, and novel imaging techniques using [18F]FAPI-74 PET/CT. These diverse strategies reflect the multifaceted approach needed to improve outcomes in colon cancer treatment.