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 given written consent to take part in the study and its related tests
• People who have been confirmed by tissue testing to have colorectal cancer that started on the left side of the colon and has spread to other parts of the body
• People whose cancer has specific genetic features: no changes (mutations) in the RAS or BRAF genes, and whose tumour has normal DNA repair activity (pMMR and/or MSS), as confirmed by an approved testing method
• People whose cancer has been assessed by a specialist medical team and judged to be not suitable for surgical removal
• People whose treating doctor plans to give them a standard chemotherapy combination called FOLFIRI together with a medicine called panitumumab as their first treatment
• People who have not yet received chemotherapy, radiation, or surgery for their spread (metastatic) cancer — though surgery on the original bowel tumour before starting treatment is permitted
• People of either sex aged 18 or older
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG scale), meaning they are fully active or have only minor limitations in physical activity
• People who have measurable disease visible on scans, assessed using standard criteria (RECIST 1.1)
• People who have had their level of a specific enzyme called DPYD tested (this is required); testing of another enzyme called UGT1A1 is recommended but not required
• People with healthy enough blood cell counts: sufficient white blood cells, platelets, and haemoglobin levels (confirm specific numbers with trial site)
• People with adequate liver function based on blood test results within acceptable ranges (confirm specific ranges with trial site)
• People with adequate kidney function based on blood test results within acceptable ranges (confirm specific ranges with trial site)
• People with normal levels of certain minerals in the blood, including magnesium, calcium, sodium, and potassium

Who may not be able to join:

• People who have had another cancer diagnosed within the past five years — exceptions include certain treated skin cancers or cervical cancer that has not spread
• People who have already received chemotherapy or other medical treatment for their metastatic colorectal cancer — though earlier chemotherapy given after surgery (adjuvant) may be allowed if it ended more than 6 months ago
• People who have had major surgery within 4 weeks before enrolling in the trial
• People who are pregnant or breastfeeding
• People who have cancer that has spread to the brain
• People who have a complete absence of DPYD enzyme activity, or who have a specific genetic variation in the UGT1A1 gene known as homozygosity
• People who have needed a reduced dose of a chemotherapy drug called 5-fluorouracil in the past due to side effects
• People with serious or poorly controlled other illnesses, or any other condition that the trial doctor believes would make participation unsafe or affect the trial results
• People with a history of difficulty cooperating with medical care or following treatment plans, or any condition that may affect their ability to understand the consent process
• People who have taken part in another clinical drug or device trial within 30 days before the start of treatment
• Sexually active people who are able to have children and are not willing to use contraception during the study and for 6 months after the last treatment
• People with a history of a lung condition called interstitial pneumonitis or pulmonary fibrosis (scarring of the lungs)
• People with a history of serious eye conditions affecting the cornea, such as perforation, ulceration, or keratitis

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