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 adenocarcinoma (a specific type of rectal cancer) confirmed by tissue biopsy within the past 90 days, where at least part of the tumour is in the lower section of the rectum
• People whose cancer has been staged using the AJCC 8th edition system as T3-4 N0 M0 or T any N1-2 M0 (meaning the cancer has grown into or through the rectal wall and may have spread to nearby lymph nodes, but not to distant parts of the body) — confirmed through scans and examination within required timeframes
• People who have had a colonoscopy performed, unless the tumour was blocking the bowel
• People with a general health status rated as ECOG Performance Status 2 or below (meaning able to carry out basic self-care, even if unable to do physical work)
• People aged 18 years or older
• People with adequate bone marrow function, meaning blood counts meet minimum levels for white blood cells, platelets, and haemoglobin (confirm specific values with trial site)
• People with adequate liver and kidney function, based on specific blood test results (confirm with trial site)
• People who a surgical oncologist has assessed as being suitable for surgery with the aim of removing all the cancer
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting chemotherapy
• Women who could become pregnant and men must agree to use an accepted form of contraception during treatment and for 3 months after chemotherapy ends
• People who are willing and able to understand and sign a written consent form

Who may not be able to join:

• People who have had previous radiation therapy in an area that would unsafely overlap with the radiation planned in this trial, as determined by the treating radiation oncologist
• People with significant heart disease that the treating oncologist considers would make it unsafe to receive the chemotherapy drugs used in this trial
• People with a serious, uncontrolled infection (grade 3 or higher)
• People with a lung or breathing condition that the treating oncologist considers would make it unsafe to receive the chemotherapy drugs used in this trial
• People who have had major surgery within 28 days before enrolling in the trial (except for a procedure to redirect the bowel called a diverting colostomy)
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) that required significant treatment, and which the investigator believes would interfere with trial therapy
• People who have had a known allergic reaction to any of the chemotherapy drugs used in this trial (5-fluorouracil, leucovorin, or oxaliplatin)
• People with a known condition called DPD deficiency, which affects how the body breaks down certain chemotherapy drugs
• People whose cancer has already spread to distant parts of the body (stage M1)
• People who are pregnant or breastfeeding
• People with a medical, psychological, or social condition that the investigator believes could increase risk or affect the person's ability to follow the trial requirements

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