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 (male or female) who have been diagnosed with rectal cancer (a specific type called adenocarcinoma), confirmed by a tissue sample, located in the rectum within a certain distance from the anal opening
• People whose cancer staging has been assessed using a high-resolution MRI scan of the pelvis, which is a required part of the assessment process
• People whose cancer meets specific MRI-based staging criteria depending on where in the rectum the tumour is located — the exact requirements differ based on whether the tumour is in the lower, middle, or upper part of the rectum (confirm with trial site)
• People who have had a CT scan of the abdomen and chest to check that the cancer has not spread to other parts of the body
• People aged 18 or older (there is no upper age limit)
• People who are generally well enough to carry out everyday activities, with only mild limitations at most (based on a standard medical fitness scale)
• People whose blood counts, kidney function, liver function, and other routine lab results fall within acceptable ranges as assessed by the trial team
• People whose heart rhythm measurement (a specific interval on an ECG called QTc) is within an acceptable range
• People who have given their informed consent to take part

Who may not be able to join:

• People whose cancer has spread to other parts of the body (distant metastases)
• People who have previously received any cancer treatment for their rectal cancer
• People who have previously had radiotherapy to the pelvic area
• People who have had major surgery in the four weeks before joining the trial
• People who are pregnant, breastfeeding, or planning to become pregnant within six months after finishing treatment
• People who are not willing to use highly effective contraception during treatment and for six months after treatment ends (this applies to both males and females)
• People who have taken part in another clinical trial in the 30 days before joining this one
• People with a current or past history of drug abuse
• People currently receiving other cancer treatments at the same time
• People with serious ongoing conditions affecting the nervous system or mental health (including dementia or uncontrolled seizures), active uncontrolled infections, or active widespread blood clotting disorders
• People who have had a significant heart condition — such as a heart attack, unstable chest pain, serious heart failure, or serious uncontrolled heart rhythm problems — within the six months before joining
• People who have ongoing diarrhoea above a mild level
• People who have had another cancer diagnosis within the past three years (exceptions may apply for certain low-risk skin cancers or early-stage cervical conditions in people who remain disease-free — confirm with trial site)
• People with a known allergy or sensitivity to the study medications or their ingredients
• People who have significant nerve-related symptoms affecting feeling or sensation in their hands or feet (above a mild level)
• People with severely reduced kidney function
• People currently being treated with a specific antiviral medicine called brivudine
• People with a particular type of anaemia caused by vitamin B12 deficiency (pernicious or megaloblastic anaemia)
• People known to have a specific genetic condition that affects how the body processes certain chemotherapy drugs (dihydropyrimidine dehydrogenase deficiency)
• People whose personal, family, social, or geographical circumstances may make it difficult to follow the trial's treatment plan and follow-up schedule

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