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:

• You have given written consent to take part
• You are currently receiving a chemotherapy regimen called Folfirinox
• You are 18 years of age or older
• Your general health and activity level meets a certain minimum standard as rated by your doctor (confirm with trial site)
• You have been diagnosed with rectal cancer (a specific type called adenocarcinoma), confirmed by a tissue sample
• Your tumor is located in a specific part of the rectum, between 1 and 12 cm from a particular internal muscle (confirm with trial site)
• A CT scan shows no clear signs that your cancer has spread to other parts of the body
• An MRI scan before treatment shows your tumor meets at least one of these conditions: it is very close to the surgical margin, it has grown significantly beyond the bowel wall with signs of blood vessel involvement, or it has grown into nearby structures (but not bone or the sphincter muscle)
• After initial chemotherapy, your tumor has shrunk by at least 60% and the surgical margin looks safe on MRI
• Your general health is considered suitable for major pelvic surgery and a chemotherapy tablet called Capecitabine
• Your blood counts, liver, kidney, and salt/mineral levels are within acceptable ranges, tested within 7 days before starting treatment
• If you are a woman who could become pregnant, you have a negative pregnancy test within 7 days before starting treatment
• If you could become pregnant or are a man who could father a child, you agree to use reliable contraception during the trial and for 6 months after finishing treatment
• You have no signs of current or long-term reduced blood supply to the heart
• You are willing and able to follow the treatment and follow-up schedule
• You are registered with the French Social Security system

Who may not be able to join:

• Your rectal tumor cannot be measured or was not assessed by MRI before joining
• Your tumor is located very low in the rectum (less than 1 cm from a specific internal muscle), which would normally require radiotherapy
• You have an active heart condition, such as moderate-to-severe heart failure, unstable chest pain, a heart attack within the last 6 months, or a heart rhythm problem requiring certain medications
• You have had a different type of cancer (other than colorectal) in the last 5 years, unless it was a fully treated early-stage cervical, skin, or bladder cancer of specific types
• You have had a blood clot, stroke, or similar event in the 6 months before starting treatment
• You have previously had radiotherapy to the pelvic area
• You have a known reason why you cannot receive chemotherapy or radiotherapy
• You have a complete or partial deficiency of an enzyme called DPD, which affects how your body processes certain chemotherapy drugs (confirm with trial site)
• You have an active infection that could affect your ability to receive treatment
• You have another serious illness (such as severe liver, heart, kidney, lung, or mental health conditions) that could interfere with your participation
• You have a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• You have a history of lung scarring (pulmonary fibrosis) or lung inflammation (interstitial pneumonia)
• You are taking a type of blood-thinning medication called antivitamin K (e.g., Coumadin/warfarin), unless you can switch to a different type of blood thinner before starting chemotherapy
• You have a known allergy to Capecitabine or any of the other study medications
• You have received a live vaccine within 10 days before joining the trial
• You are pregnant or breastfeeding, or you are of childbearing age and do not have a confirmed negative pregnancy test within 72 hours before joining
• You have taken part in another clinical drug trial within the last 30 days
• You are under legal guardianship or a similar protective legal arrangement
• You are unable to attend regular medical monitoring for the trial due to geographical, social, or personal reasons

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