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 after having the study fully explained to them
• People who have been confirmed through a tissue test (biopsy) to have rectal adenocarcinoma (a specific type of rectal cancer)
• People whose cancer has not spread to distant parts of the body, and for whom surgery to remove the cancer is considered possible
• People who are 18 years of age or older at the time of giving consent
• People with a good general health and activity level — specifically, a performance score of 0 or 1 on a standard medical scale (ECOG), or a score of 0 only if aged 70 or older (confirm with trial site)
• People whose tumour is located within 12 cm of the anal opening
• People who have not had any prior treatment for this cancer
• People who have never had radiation therapy to the pelvis for any reason, including past treatment for a different cancer
• People whose cancer stage falls within certain specific categories based on international staging guidelines (UICC 8th edition: cT3-4N0M0 or T1-4N1-2M0); some lower-risk stage groupings within this range are only eligible for people who have declined surgery (confirm with trial site)
• People with a normal or single-copy variation in a gene called UGT1A1, which affects how certain medications are processed by the body
• People whose blood and organ function test results from within the past 28 days meet specific minimum levels for white blood cells, platelets, haemoglobin, liver function, and kidney function (confirm with trial site for exact values)

Who may not be able to join:

• People who have had major surgery (other than a colostomy or placement of a central venous port) within 4 weeks before starting treatment
• People who have a serious lung condition, such as interstitial lung disease, pulmonary fibrosis, or severe emphysema, either currently or in their medical history
• People who currently have a colonic stent (a small tube placed inside the bowel)
• People who cannot have an MRI scan, for example because they have a cardiac pacemaker
• People with serious ongoing health conditions such as heart failure, kidney failure, liver failure, bowel paralysis, bowel obstruction, uncontrolled diabetes, or active inflammatory bowel disease
• People who have, or have recently had, more than one active cancer — unless the other cancer was a very early-stage lesion that was fully treated with a simple local procedure (confirm with trial site)
• People who are pregnant, breastfeeding, have a positive pregnancy test, or are unwilling to use contraception during the trial
• People who test positive for Hepatitis B surface antigen, or who test positive for Hepatitis C antibodies and also have detectable Hepatitis C virus in their blood
• People who have an HIV infection
• People whose cancer is known to have a specific genetic feature called MSI-high (MSI-H) or deficient mismatch repair (dMMR)
• People who are unwilling to provide tissue or biological samples for a linked whole-genome research study called the CONDUCTOR study
• People considered unsuitable for the trial for any other reason, at the judgement of the lead or co-investigator

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