Phase 3 Colorectal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a specific type of colon cancer (adenocarcinoma) confirmed by biopsy, including cancers in the upper part of the rectum if radiotherapy is not needed for that area
• People whose cancer has spread to nearby tissue or lymph nodes but not to distant parts of the body, based on scans (stage T3 or T4, with or without lymph node involvement, and no distant spread)
• People whose cancer does not show signs of blocking the bowel, confirmed by scans and camera examination
• People aged 70 or older at the time of joining the trial
• People whose tumour has a specific biological profile called pMMR/MSS (a laboratory marker checked on the tumour tissue)
• People who a specialist doctor considers well enough to receive 6 weeks of chemotherapy (called FOLFOX, given in 3 rounds) followed by surgery
• People whose body processes a certain chemotherapy-related substance at a safe level (uracilemia below 16 ng/ml — confirm with trial site)
• People with adequate blood cell counts, including white blood cells, platelets, and neutrophils above specified levels (low haemoglobin alone does not automatically exclude someone, as this may be corrected before treatment)
• People with adequate levels of certain minerals in the blood (calcium, magnesium, and potassium above specified levels)
• People whose kidneys are functioning well enough, based on a measure called GFR being above 50 ml/min
• People whose liver is functioning within acceptable limits, based on specific blood test results
• People who are able to understand the study and are willing to sign a written consent form
• People who are covered by a social security scheme
• People with multiple colon tumours at the same time may be eligible if the most advanced tumour meets all the criteria above

Who may not be able to join:

• People for whom the medical team recommends radiotherapy as part of their treatment
• People with confirmed spread of cancer to distant parts of the body or to the lining of the abdomen (peritoneal metastases)
• People whose bowel has perforated (burst), causing infection in the abdomen
• People whose tumour is at an earlier stage (T1 or T2)
• People with serious uncontrolled medical conditions, such as uncontrolled chest pain (angina), as assessed by the treating doctor
• People who have had another cancer in the past 5 years, except for certain low-risk cancers such as some skin cancers, very early-stage cancers, or cancers with a very low chance of coming back
• People whose tumour has a different biological profile known as dMMR or MSI-H
• People who have nerve damage in their hands or feet that affects their daily functioning (grade 2 or higher peripheral neuropathy)
• People who have taken or are currently taking specific antiviral medications (brivudine, sorivudine, or similar drugs) within four weeks before joining the trial
• People under legal guardianship or who have had their legal freedoms restricted
• People who are unable to attend follow-up appointments for geographical, social, or psychological reasons
• People with a known allergy to any of the trial treatment ingredients
• People whom the treating doctor considers to be in poor nutritional health
• People with a condition affecting bone marrow function
• People who have had a serious infection within one month before starting chemotherapy
• People who have received certain live vaccines (such as yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus, or influenza) within one month before starting chemotherapy
• People who have had significant heart disease or a heart attack within the past 6 months
• People with ongoing uncontrolled liver, kidney, or breathing problems over the past 6 months
• People with a specific heart rhythm measurement (QT/QTc interval) above the accepted limit for their sex
• People with pernicious anaemia or anaemia caused by a lack of vitamin B12

Important: Always verify eligibility with the trial site directly before applying.