Phase 3 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:

• People aged 18 or older who have given their written consent to participate.
• People who have been confirmed through a tissue biopsy to have colorectal cancer (cancer of the colon or rectum) that is classified as adenocarcinoma.
• People whose colorectal cancer has spread (metastasised) and whose metastases have been surgically removed or effectively treated using any approved technique, within 3 to 10 weeks before joining the trial, and whose original bowel tumour has also been removed.
• People who have no significant wound healing problems at the time of joining (minor resolved healing issues after surgery or ablation are acceptable).
• People who have no visible signs of active cancer spread on a CT or MRI scan taken within the 10 weeks before joining the trial.
• People with a general health and activity level rated as reasonably good (confirm with trial site for the specific rating scale used).
• People whose blood, liver, and kidney test results meet the required levels set by the trial (the trial site will check these through standard blood tests).
• People whose blood clotting levels are within an acceptable range, or who are already on blood thinning medication.
• People who have previously tolerated a common chemotherapy drug called 5-FU or capecitabine without unusual side effects, or whose genetic test results show they can safely process these drugs (confirm with trial site for details, as dose adjustments may apply in some cases).
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining and must agree to use highly effective contraception during treatment and for at least 6 to 9 months after the last dose, depending on which drug was last received.
• Men with female partners who could become pregnant must agree to use a condom plus an additional highly effective contraceptive method during treatment and for 6 months after the last dose, and must not donate sperm during this period.

Who may not be able to join:

• People who had ablation treatment (such as radiofrequency or microwave ablation) on metastases larger than 3 cm within the past 24 months.
• People who had radiation treatment on metastases larger than 5 cm within the past 24 months.
• People who have previously received more than a total of six months of chemotherapy containing oxaliplatin (specific limits apply — the trial site will assess this individually).
• People with severe heart failure (confirm with trial site for the specific classification used).
• People who have had a heart attack or a coronary artery procedure (such as stenting or balloon treatment) within the past 6 months.
• People with unstable chest pain (angina).
• People with serious, uncontrolled irregular heart rhythms despite medication to treat them.
• People who currently have ongoing side effects from previous treatment that are considered more than mild (confirm with trial site for the specific grading used).
• People with an active infection that is not under control, in the treating doctor's assessment.
• People with serious non-healing wounds, open sores, or untreated broken bones.
• People with a known allergy or sensitivity to any of the chemotherapy drugs used in this trial, including 5-FU, folinic acid, irinotecan, oxaliplatin, or capecitabine.
• People currently taking or recently treated with a medication called brivudine.
• People who have nerve damage in their hands or feet that is causing functional problems (beyond very mild symptoms).
• People with inflammatory bowel disease or a bowel blockage.
• People currently using St. John's Wort herbal preparations.
• People with a specific type of anaemia caused by vitamin B12 deficiency (pernicious or megaloblastic anaemia).
• People who have had major surgery, an open biopsy, or a serious injury within 21 days before joining, or who are expected to need major surgery during the trial, or who have not yet recovered from a recent procedure.
• People with any other serious illness, medical condition, or abnormal test result that the treating doctor considers would make participation unsafe or affect the trial results.
• People with a history of another cancer, with some exceptions: people who have been cancer-free for at least three years may be considered; people with certain fully treated and removed skin cancers or early-stage cancers may also be considered; and people with a previously treated cancer that carries a 5-year survival rate of 90% or more and does not currently require active treatment may also be considered (confirm with trial site).
• People with a known history of alcohol or drug misuse.
• Women who are pregnant or breastfeeding.
• People who have taken part in another clinical trial or received an experimental treatment within 28 days before potentially joining this trial, or within five half-lives of the experimental substance used — whichever period is longer — or who would be in another trial at the same time as this one.
• People who are in a dependent relationship with the trial sponsor, investigator, or study site.
• People with a suspected or confirmed SARS-CoV-2 (COVID-19) infection at the time of joining (the trial site will assess this according to local guidelines).
• People who are in institutional care by order of a court or government authority.
• People who do not have full legal capacity to consent.
• People taking certain strong medications that affect how the body processes irinotecan or oxaliplatin, including drugs such as rifampicin, carbamazepine, phenobarbital, phenytoin, or apalutamide (confirm with trial site for full list).
• People who are planning to receive a live vaccine during treatment with oxaliplatin or irinotecan, or within 6 months after completing irinotecan treatment.

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