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:

• Adults aged 18 or older, of any gender
• People who are in good general health, with a performance score showing they are fully active or have only minor restrictions on physical activity (ECOG score of 0 or 1)
• People who have been diagnosed through a tissue biopsy with cancer of the appendix or colorectal (bowel) cancer that has spread to the lining of the abdomen (peritoneal carcinomatosis), whether this spread was found within 12 months of the original diagnosis or more than 12 months later
• People who have completed full staging investigations, including a CT scan of the chest, abdomen and pelvis; a PET scan if considered appropriate by their medical team; and a keyhole surgical assessment of the abdomen that measures how far the cancer has spread (confirm with trial site)
• People whose case has been reviewed and recommended for a specific surgical and chemotherapy treatment (cytoreductive surgery combined with heated chemotherapy delivered directly into the abdomen, followed by a further chemotherapy protocol called mEPIC) by a specialist multidisciplinary team
• People whose surgery is planned to take place within 4 to 6 weeks after finishing any pre-surgery chemotherapy, or within 4 to 6 weeks of joining the trial if no pre-surgery chemotherapy is needed
• People who are willing and available to follow all study procedures for the full duration of the trial and have signed and dated a consent form
• People with blood counts showing an adequate number of neutrophils (infection-fighting white blood cells) and platelets (confirm specific levels with trial site)
• People with adequate kidney function based on blood test results (confirm specific levels with trial site)
• People with adequate liver function based on blood test results, including those with a condition called Gilbert's Syndrome, who are assessed under slightly different thresholds (confirm with trial site)

Who may not be able to join:

• People who have a cancer other than appendix or colorectal cancer that has spread to the abdominal lining
• People whose general health means they would be unable to complete the surgery (ECOG score of 2 or higher), or who are otherwise considered unfit for surgery by their medical team
• People who have had a known serious allergic reaction or major side effects from the chemotherapy drug Fluorouracil
• People who have medical reasons preventing the use of Fluorouracil, including a history of coronary artery spasm or a known enzyme deficiency that affects how the body processes this drug
• People who are pregnant
• People found to have extensive internal scarring in the abdomen at the time of surgery that prevents chemotherapy from being delivered directly into the abdomen, as assessed by the operating surgeon
• People with any other condition that would prevent the safe delivery of chemotherapy directly into the abdomen
• People who, after surgery, are considered by the surgical team to be medically unsuitable to receive the post-surgery chemotherapy protocol (mEPIC)
• People who, after surgery, have uncorrected blood clotting problems, low platelet counts, or low white blood cell counts
• People with an active infection at the time of post-surgery treatment
• People experiencing significant heart or breathing problems after surgery
• People found after surgery to have extensive internal abdominal scarring preventing chemotherapy delivery into the abdomen, as assessed by the operating surgeon

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