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:

• Adults aged 18 or older
• People who are generally well and able to carry out daily activities with little or no limitation (as measured by a standard health scale used by doctors)
• People who have a blockage-causing colon cancer that has been managed with a temporary opening in the abdomen (called a stoma) to divert bowel movements
• People whose cancer has been confirmed by laboratory testing as a specific type called adenocarcinoma, located in a particular section of the colon (not in the lower rectum), and whose tumour has a specific molecular profile (called MSS or pMMR — confirm with trial site if unsure what this means for a specific case)
• People who need surgery to remove part of their colon
• People whose recent blood test results fall within required ranges for blood cell counts, liver function, kidney function, and other measures (tested 10–15 days before joining the trial)
• People whose cancer has not spread to the lungs, liver, or the lining of the abdomen, as confirmed by a full body scan
• People who do not have a second separate colorectal cancer at the same time
• People who have not had chemotherapy or radiation to the abdomen or pelvis before
• People with no previous history of colorectal cancer
• People without serious uncontrolled medical conditions (such as uncontrolled inflammatory bowel disease, uncontrolled chest pain, or a heart attack in the past 6 months) that could affect the ability to tolerate chemotherapy or surgery
• Women who could become pregnant and who are using effective contraception, and who have a negative blood pregnancy test at the time of joining
• Women who have had surgical removal of their ovaries and/or uterus
• Women who have gone through natural menopause, confirmed by at least 12 months without a period (not caused by medication)
• Men who agree to use contraception during the trial and for 6 months after finishing chemotherapy
• People who are able to follow the study requirements, in the treating doctor's judgement
• People enrolled in a national health insurance scheme (as required under the study's country of operation)
• People who have been fully informed about the trial and have signed a consent form

Who may not be able to join:

• People for whom colon surgery or general anaesthesia is not medically safe
• People whose cancer is located in the rectum (within 10 cm of the anal opening, or below a certain point inside the abdomen as identified during surgery)
• People who have already received radiation therapy before surgery
• People whose cancer has already spread to the lungs, liver, or lining of the abdomen at the time of assessment
• People with a current or past condition affecting the brain or nervous system, or who already have any degree of nerve damage (peripheral neuropathy)
• People for whom the chemotherapy drugs used in this trial are not medically suitable
• People with inflammatory bowel disease, a hereditary bowel cancer syndrome (HNPCC), or bowel polyp conditions
• People with significant heart artery disease, a heart attack in the last 6 months, or a high risk of serious irregular heartbeat
• People with a particular enzyme deficiency affecting how the body processes certain chemotherapy drugs (uracil level of 150 ng/ml or above, which may suggest complete DPD deficiency)
• People whose personal, medical, geographical, or legal circumstances would prevent them from completing the study or signing a consent form
• People with any other significant illness that, in the treating doctor's opinion, would make participation unsuitable
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months of finishing treatment
• People who are subject to a legal order restricting their liberty, or who are under legal guardianship or supervision
• People already taking part in another interventional clinical trial at the same time

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