Phase 2 Colorectal Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, scoring 0 or 1)
• People who have given their written agreement to take part in the trial
• People whose liver, kidneys, and other organs are functioning at an acceptable level (confirm with trial site for specific details)
• People who agree to use highly effective birth control during the trial, if there is any chance of becoming pregnant or fathering a child (confirm with trial site for specific details)
• People whose bowel cancer (colon or rectal cancer) has been confirmed by tissue testing and belongs to a specific type known as pMMR/MSS adenocarcinoma
• People whose cancer has spread and cannot be fully removed by surgery at the time of joining the trial
• People who have a tumour growth (either the original or a spread) that can be sampled by a small tissue collection procedure called a biopsy
• People whose cancer can be measured or tracked using standard imaging methods
• People for whom an experienced doctor has independently assessed both standard chemotherapy options — one oxaliplatin-based (FOLFOX, with or without a targeted antibody medicine) and one irinotecan-based (FOLFIRI, with or without a targeted antibody medicine) — as equally suitable as a first treatment, in line with Norwegian national guidelines for colorectal cancer
• People who are able to receive the full recommended doses of chemotherapy from the very first treatment cycle
• People for whom treatment can be scheduled to start within 28 days of being referred to the trial

Who may not be able to join:

• People whose cancer is of a different molecular type, known as MMR deficient or MSI
• People who are not able to receive full chemotherapy doses from the first treatment cycle
• People for whom a doctor has not assessed both FOLFOX and FOLFIRI as equally suitable options under Norwegian national guidelines
• People with an ECOG performance status of 2 or worse, meaning their cancer or health significantly limits daily activity
• People who are pregnant or planning to become pregnant during the study, due to potential risks of the medicines to an unborn baby
• People who are breastfeeding
• People whose personal, psychological, geographical, or family circumstances may make it difficult to follow the trial procedures
• People who are unable to understand or follow the study procedures, or whose condition affects their ability to give informed consent
• People who have a known medical reason they should not take one of the trial medicines, based on official medicine safety information
• People for whom treatment cannot be scheduled within 28 days of referral
• People with a partial or complete inability to break down certain chemotherapy drugs, due to a condition called DPD deficiency
• People with cancer that has spread to the brain or central nervous system
• People who still have significant side effects from a previous cancer treatment that their doctor considers make them unsuitable for the trial
• People who have received anti-cancer treatment within 30 days before joining (hormone replacement therapy is allowed)
• People with serious pre-existing heart conditions, such as unstable chest pain, uncontrolled irregular heartbeat, a known very low heart pumping function, or significant heart failure
• People who have had a stroke, mini-stroke (TIA), or heart attack within the 6 months before starting trial treatment
• People with significant nerve damage causing sensory problems, particularly in the hands or feet
• People who have had a serious blood clot event, such as a pulmonary embolism or deep vein thrombosis, within the 6 months before starting trial treatment
• People with a history of, or current signs of, scarring or inflammation in the lungs (interstitial pneumonitis or pulmonary fibrosis), including findings on a chest scan
• People who have previously had a serious allergic reaction to any component of the trial medicines
• People with a history of any other disease that may increase the risks of taking part in the trial

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