Phase 2 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 with rectal cancer that has been confirmed by a tissue sample (biopsy), where the tumour is located in a specific part of the rectum (between 0 and 12 cm from the anal opening)
• People whose cancer has been staged by MRI scan as early-to-moderate stage — specifically, the tumour has not grown deeply into surrounding tissue (cT1–cT3), has not spread to many lymph nodes (cN0–cN1), and has not spread to distant parts of the body (cM0)
• People with very early-stage (Stage I) tumours, but only where endoscopic (camera-based) removal is not suitable, or where standard surgery would require a permanent colostomy bag or is expected to result in poor bowel function
• People whose tumour covers less than 70% of the inner wall of the rectum
• People whose tumour measures less than 8 cm in length as seen on MRI
• People who have had a high-quality, detailed MRI scan of the pelvis with thin image slices (3mm or less)
• People who have had imaging scans of the abdomen and chest to check that 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 daily activities with little or no limitation (this is measured using a standard health scale; confirm with trial site)
• People with blood, liver, kidney, and general body chemistry results within an acceptable range (confirm with trial site)
• People who have given their informed written consent to participate

Who may not be able to join:

• People whose tumour begins more than 12 cm from the anal opening, as measured by a specific type of rectal examination using a rigid instrument
• People whose cancer has already spread to other parts of the body (distant metastases)
• People who already have difficulty controlling their bowel movements for solid stool before the trial begins
• People who have previously received any cancer treatment for rectal cancer
• People who have previously had radiotherapy to the pelvic area
• People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing treatment
• People who are not willing to use highly effective contraception during treatment and for 6 months after treatment ends (this applies to both males and females)
• People who are currently receiving other cancer treatments at the same time
• People with serious ongoing illnesses, including uncontrolled neurological or psychiatric conditions (such as dementia or uncontrolled seizures), active and uncontrolled infections, or active widespread blood clotting disorders
• People who have another type of cancer that is expected to reduce life expectancy to less than three years
• People for whom the chemotherapy drugs used in this trial (5-Fluorouracil or Capecitabine) are medically unsuitable
• People whose personal, family, social, or geographical circumstances may make it difficult to follow the trial's treatment plan and attend follow-up appointments (the trial site would discuss this with the person before registration)

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