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 who have been diagnosed through a biopsy with a type of rectal cancer called invasive rectal adenocarcinoma that is well or moderately developed (not the most aggressive type), and whose cancer has a normal DNA repair system.
• People whose cancer stage, as seen on an MRI scan, meets specific size and spread criteria — either a smaller early-stage tumour not suitable for a particular local surgical approach, or a tumour that has grown only slightly beyond the rectal wall (up to 5mm).
• People whose MRI scan shows no signs of cancer spread to nearby lymph nodes, tumour deposits, or spread into nearby blood vessels.
• People whose CT scan of the chest, abdomen, and pelvis shows no signs of cancer having spread to other parts of the body.
• People whose tumour is located in the middle to lower part of the rectum and is considered suitable for a local surgical removal through the anal canal, in the opinion of the treating surgeon.
• People who are considered medically well enough to undergo major rectal surgery if needed, as assessed by the treating surgeon.
• People who are able and willing to complete quality of life questionnaires in English, French, or Spanish.
• People aged 18 years or older.
• People who have no medical reasons preventing them from receiving the chemotherapy planned in this trial.
• People whose blood counts and organ function meet specific minimum levels — including white blood cell counts, platelet counts, liver function, and kidney function (confirm with trial site for exact values).
• People who are generally active and able to carry out daily activities, with limited restriction — rated using a standard medical scale (confirm with trial site).
• People who are able to attend all required treatment appointments and follow-up visits.
• People of reproductive potential who have agreed to use a highly effective form of contraception during chemotherapy and for 6 months after it ends.
• People living with HIV who are on effective treatment and have had an undetectable level of virus in the blood within the past 6 months.

Who may not be able to join:

• People whose biopsy shows a high-grade (poorly differentiated), mucinous, or signet ring type of rectal cancer.
• People whose MRI scan shows visible lymph nodes on the side walls of the pelvis.
• People where the treating doctor clearly determines that lymph node involvement would prevent safe delivery of the trial treatment.
• People who have previously had radiation therapy to the pelvis for any reason, including a type called brachytherapy.
• People who have already had their tumour fully removed before joining the trial. Those who have had a partial removal may still be considered, but only if cancer is still clearly visible on examination.
• People who have a separate or previous cancer whose treatment or progression could interfere with assessing the safety or effectiveness of this trial's treatment.
• People who have already received any treatment for their rectal cancer.
• People who are known to have a genetic condition called dihydropyrimidine dehydrogenase (DPYD) deficiency, which affects how the body processes certain chemotherapy drugs.
• People who have not yet recovered from significant side effects of a previous treatment or procedure.
• People with a known history of heart disease or who have received treatments that can affect the heart, and whose heart function is assessed as below a certain level using a standard heart health rating scale (confirm with trial site).
• People who cannot have an MRI scan for any medical reason.
• People whose tumour is located at the front of the rectum, at or above a certain internal boundary, making local surgical removal through the anal canal not possible.
• People with a T3-stage tumour that is growing into or pressing against the inner sphincter muscle of the rectum.

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