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 who are in good general health, able to carry out normal daily activities with minimal limitations (rated 0 or 1 on a standard medical fitness scale called ECOG).
• People who have been confirmed by lab testing to have Stage IIB, IIC, or Stage III colon cancer (a type called adenocarcinoma), where surgery successfully removed all visible cancer with clear margins (called R0 resection).
• People who have had no signs of cancer spread to other parts of the body on imaging scans (CT or MRI of the chest, abdomen, and pelvis) done within 45 days before joining the study.
• People whose tumour was located in the colon (not the rectum), confirmed to be at least 12 cm from the end of the bowel passage, meaning rectal cancers that would normally require radiation treatment are excluded.
• People who had a complete surgical removal of the tumour, including those who had a two-stage procedure (first a colostomy, then the main surgery to remove the cancer).
• People whose tumour tissue and a blood sample can be tested for a specific marker called ctDNA using the Signatera™ test, with the blood sample collected after surgery (ideally at least 14 days after).
• People whose tumour has been tested and confirmed to be microsatellite stable (MSS) or has intact mismatch repair proteins, through an approved laboratory test.
• People who, in their treating doctor's judgement, are considered suitable to receive all the chemotherapy medicines used in this trial (5-FU, leucovorin, oxaliplatin, and irinotecan).
• People who enrol within 60 days of their surgery (no earlier than 7 days after surgery).
• People who have enough tumour tissue available from surgery for additional laboratory testing.
• People with adequate blood counts within 28 days before joining, meaning: white blood cell levels (neutrophils) at or above 1,500 per mm³ (or below 1,300 per mm³ if the person has a benign inherited condition causing naturally lower neutrophil counts, more common in people of African descent); platelets at or above 100,000 per mm³; and haemoglobin at or above 9 g/dL.
• People with adequate liver function within 28 days before joining, with bilirubin, alkaline phosphatase, and liver enzymes (AST and ALT) all within acceptable ranges set by the testing laboratory.
• People with adequate kidney function within 28 days before joining, based on creatinine levels or a calculated measure of how well the kidneys filter the blood.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• Women who could potentially become pregnant must have a negative pregnancy test (urine or blood) within 14 days before joining.
• People taking a blood-thinning medication called a coumarin-based anticoagulant (such as warfarin) who agree to weekly INR monitoring if assigned to certain treatment groups in the trial.

For a specific group within the trial (Cohort A, Arm 2 — second randomisation stage):

• People in this group whose ctDNA blood test has come back positive during ongoing monitoring after their first enrolment.
• People who are willing to be re-assigned to a new treatment group.
• People who still meet the fitness, scan, blood, liver, and kidney requirements described above at the time of the second assignment, and women who could potentially become pregnant must have a negative pregnancy test within 14 days before the second assignment.

Who may not be able to join:

• People whose colon cancer is a type other than adenocarcinoma (for example, neuroendocrine carcinoma, sarcoma, lymphoma, or squamous cell carcinoma).
• People with confirmed or visible signs of cancer that has spread to other parts of the body, including isolated areas in the abdomen, even if those areas were surgically removed.
• People whose tumour caused the bowel to rupture (perforate).
• People with a previous history of invasive colon cancer, regardless of how long ago it occurred.
• People who have previously had a bone marrow or solid organ transplant (note: bone grafts, skin grafts, corneal transplants, and organ donation do not disqualify someone).
• People who have already received chemotherapy, targeted therapy, immunotherapy, or radiation as treatment for colorectal cancer — with one exception: one optional cycle of standard chemotherapy (5-FU or capecitabine, with or without oxaliplatin) may be allowed after consent and at least 4 weeks after surgery, while waiting for the next stage of the trial.
• People who have had another invasive cancer within the past 5 years, with exceptions for non-cancerous colon polyps, non-melanoma skin cancers, or carcinoma-in-situ (very early-stage, non-invasive abnormal cells).
• People with more than one primary colon or rectal cancer occurring at the same time.
• People with a history of significant heart disease or treatment with heart-damaging medications whose heart function is assessed as worse than Class 2B on the standard New York Heart Association scale (confirm with trial site).
• People with moderate to severe nerve damage affecting sensation or movement (Grade 2 or higher on a standard medical grading scale).
• People who had a blood transfusion within two weeks before the blood sample collected for the ctDNA test.
• People with an active seizure disorder that is not controlled by medication.
• People with an active or ongoing infection that requires systemic (whole-body) treatment.
• People known to have a complete deficiency of an enzyme called DPD (dihydropyrimidine dehydrogenase), which affects how certain chemotherapy drugs are processed by the body.
• People known to have Gilbert's Syndrome or a specific inherited genetic variation called homozygous UGT1A1*28, which affects how certain drugs are broken down.
• People who are pregnant or breastfeeding at the time of joining the trial.
• People with other serious health conditions that would make it unsafe or inappropriate for them to receive six months of combination chemotherapy, or that would interfere with accurately monitoring the safety of the treatment.

For the specific group re-joining at the second randomisation stage (Cohort A, Arm 2):

• People who are pregnant or breastfeeding at the time of the second assignment.
• People who are no longer considered suitable for combination chemotherapy (FOLFOX, CAPOX, or mFOLFIRINOX) in their treating doctor's judgement.

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