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 between 18 and 75 years old
• People who have been diagnosed with rectal cancer (specifically a type called adenocarcinoma), confirmed by tissue testing
• People whose tumour is located close to the anal opening (5 cm or less away) and where the cancer has grown through the bowel wall and into nearby lymph nodes, but has not spread to distant parts of the body or invaded neighbouring organs, and where doctors believe full surgical removal of the tumour is possible
• People whose tumour is located further from the anal opening (more than 5 cm away) and where the cancer has grown significantly through the bowel wall and into nearby lymph nodes, but has not spread to distant parts of the body or invaded neighbouring organs, and where doctors believe full surgical removal is possible
• People who have had specific scans and examinations to assess the cancer stage, including a rectal examination, high-resolution MRI scan, and/or internal ultrasound (EUS), as well as chest and abdominal CT scans to check for spread
• People whose tumour, as confirmed by MRI, is located within 12 cm of the anal opening
• People who do not have a bowel blockage, or whose blockage has already been relieved by a temporary colostomy (a surgical opening to redirect bowel waste)
• People who have not previously had rectal surgery, chemotherapy, radiation therapy, or biological treatments for this condition (hormonal therapy is an exception)
• People who are generally well enough to carry out light activity and care for themselves, as assessed by a standard medical scale (ECOG score of 0 or 1)
• People with a life expectancy of more than 2 years
• People whose blood test results fall within acceptable ranges, including normal levels of white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, and kidney function markers

Who may not be able to join:

• People whose cancer has grown into surrounding organs or tissues (a stage known as T4b)
• People whose cancer has spread to a specific group of lymph nodes in the pelvis called the obturator lymph nodes
• People with certain heart conditions, including irregular heart rhythms requiring medication (other than beta-blockers or digoxin), significant coronary artery disease, a heart attack within the past 6 months, or moderate-to-severe heart failure
• People with high blood pressure that is not well controlled
• People with a history of HIV, or who currently have an active hepatitis B or C infection with high levels of the virus detected
• People with other serious active infections
• People where scans show the cancer has already spread to areas outside the pelvis
• People who are significantly malnourished or whose major organs are not functioning adequately
• People who have previously had radiation therapy to the pelvis or abdomen
• People with more than one primary cancer at the same time
• People with epilepsy who are currently receiving treatment for it (including steroids or anti-epileptic medication)
• People who have had another type of cancer within the past 5 years, except for certain fully treated skin cancers or cervical cancer in its earliest stage
• People whose substance use, or mental, psychological, or social circumstances may interfere with safe participation in the trial
• People who have a known allergy to any of the medications used in this study
• People with any unstable health condition that could put their safety at risk during the trial
• People who are pregnant, breastfeeding, or not using adequate contraception

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