Phase 1 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 18 or older
• People who have been diagnosed with rectal cancer (specifically a type called adenocarcinoma), confirmed by a tissue or cell sample
• People whose cancer has been assessed as stage I, II, or III (meaning it has not clearly spread to other parts of the body)
• People with no confirmed spread of cancer to other organs, or only unclear/uncertain signs of possible spread (such as small spots on the lung or liver that cannot be clearly identified on scans), as decided by a specialist medical team
• People with a reasonable level of physical functioning, assessed within 45 days of joining the study (confirm with trial site)
• People who have had a physical exam, weight measurement, and vital signs recorded within 45 days before starting treatment
• People who are able to have MRI scans of the rectum and abdomen for staging, treatment planning, and follow-up
• People who have had a chest CT scan within 45 days before joining the study
• People whose blood test results within 45 days before treatment meet specific minimum levels for white blood cells, platelets, haemoglobin, and liver-related markers (confirm with trial site for exact values; a blood transfusion to meet the haemoglobin requirement is acceptable)
• People who are not on kidney dialysis
• People who are able to swallow tablets or capsules
• People who a cancer specialist has determined are suitable for chemotherapy
• People who have provided signed consent to participate in the study
• People who have had a negative pregnancy test, if applicable
• People of childbearing potential, and male participants who are sexually active, who are willing and able to use adequate contraception during the study

Who may not be able to join:

• People who have confirmed cancer spread to distant parts of the body, or where the specialist medical team has reached a consensus that the cancer is stage IV
• People who have had another type of invasive cancer in the past, unless it was a non-melanoma skin cancer, non-invasive breast cancer (DCIS), or prostate cancer currently being monitored without treatment — other past cancers may be considered if the person has been cancer-free for at least three years
• People who have previously had radiation therapy to the same area of the body where the current cancer is located, if the radiation fields would overlap
• People who have had major surgery within 28 days before joining the study, with some exceptions such as placement of a colon stent, bowel diversion without removal of bowel, or insertion of a vascular access device
• People with serious active health conditions, including: unstable chest pain or heart failure requiring hospitalisation in the past six months; a serious heart attack within the past three months; an active bacterial or fungal infection currently being treated with intravenous antibiotics; a severe lung condition flare-up or breathing illness requiring hospitalisation within the past 30 days; an uncontrolled condition that severely affects the body's ability to absorb nutrients; any unresolved bowel blockage; or AIDS as defined by current public health guidelines (HIV testing is not required to join, but people with AIDS may not be eligible due to possible interactions between HIV medications and study drugs)
• People whose overall health means major bowel surgery would not be considered appropriate for them (confirm with trial site)
• People who are pregnant, or people of childbearing potential and sexually active male participants who are unwilling or unable to use appropriate contraception during the study and for the required period after treatment ends (three months for women, six months for men) — this is because the study treatments may be harmful to an unborn baby
• People currently participating in another clinical trial that involves an experimental treatment (observational studies are allowed)
• People currently taking chemotherapy or immune-modifying medications outside of this study's protocol — any questions about specific medications should be reviewed with the study's principal investigator
• People whose physical condition means they are unable to be positioned properly for radiation treatment
• People with an allergy to gadolinium (a substance used in MRI contrast scans)
• People over the age of 60 who have a history of high blood pressure, diabetes, or a liver transplant, and whose kidney function (measured by GFR) is below 30 at the time of enrolment

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