Phase 3 Bladder 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 urothelial carcinoma (a type of bladder cancer) confirmed by laboratory testing, at a specific stage (cT2-T3, N0M0 — meaning the tumour has grown into the bladder wall but has not spread to lymph nodes or other parts of the body) before being assigned to a treatment group
• People who have undergone a surgical procedure called TURBT (where a surgeon removes as much of the bladder tumour as possible through the urethra) before being assigned to a treatment group
• People who have had imaging scans (CT or MRI, or FDG-PET scan) of the chest, abdomen, and pelvis to check the extent of the cancer, with results showing no spread to lymph nodes or beyond the bladder
• People who, if any lymph nodes appeared enlarged on their scans, have had a biopsy of those lymph nodes confirming no cancer involvement
• People who do not have widespread carcinoma in situ (a flat, non-invasive type of cancer growth) throughout the bladder, as confirmed by camera examination and biopsy
• People who show no clear signs of cancer that has spread to other parts of the body
• People who have not had urothelial carcinoma anywhere outside the bladder in the past 24 months — with one exception: a specific type of upper urinary tract cancer (in the kidney or ureter) may be acceptable if the entire affected kidney and ureter were surgically removed
• People aged 18 or older
• People who are generally able to carry out daily activities, rated on a standard performance scale (Zubrod score of 2 or lower, meaning they may have some symptoms but are not confined to bed more than half the day)
• People who are not pregnant and not breastfeeding; those who could potentially become pregnant must have a negative pregnancy test within 14 days before registration
• People whose blood test results meet minimum levels for white blood cells, platelets, and haemoglobin (red blood cell levels must be at least 8.0 g/dl, which can be achieved with a transfusion if needed)
• People whose kidneys are functioning well enough, based on a calculation called Cockcroft-Gault (kidney clearance rate of at least 30 mL/min)
• People whose liver function blood tests are within acceptable ranges (bilirubin no more than twice the normal upper limit; liver enzymes AST and ALT no more than three times the normal upper limit)
• People who have recovered from side effects of any previous treatment to an acceptable level (grade 3 or lower on a standard medical scale) before being assigned to a treatment group
• People who completed pre-surgery (neoadjuvant) treatment, provided their original bladder tumour was confirmed by laboratory testing within 180 days before being assigned to a treatment group
• People who have never had radiation treatment to the pelvic area
• People whose heart function is rated as Class II or better on the New York Heart Association scale (meaning they can carry out ordinary physical activity with only mild limitations at most)
• People who do not have an active infection currently requiring antibiotics given through a drip (intravenously)
• People who have a blocked urinary drainage system (hydronephrosis) on one side only, provided their kidney function results meet the required levels

Who may not be able to join:

• People whose bladder cancer contains small cell carcinoma (a specific cancer type), even if mixed with urothelial carcinoma
• People whose imaging shows the cancer has reached stage T4 (spread beyond the bladder into nearby structures) or has spread to lymph nodes
• People with widespread carcinoma in situ (flat cancer growth) throughout the bladder
• People with clear signs that the cancer has spread to distant parts of the body
• People who have had urothelial carcinoma at any site outside the bladder within the past 24 months (unless it was a specific type in the upper urinary tract that was fully removed by surgery)
• People who are pregnant or breastfeeding, or people who could become pregnant and do not have a negative pregnancy test result within 14 days before registration
• People whose blood counts, kidney function, or liver function test results fall below the required minimum levels
• People who still have significant unresolved side effects from previous treatments (above grade 3 on a standard medical scale)
• People who have previously had radiation treatment to the pelvic area
• People whose heart function is rated as Class III or IV on the New York Heart Association scale (meaning significant limitation of physical activity or symptoms even at rest)
• People currently being treated for an active infection with antibiotics given through a drip
• People who have hydronephrosis (blocked urinary drainage) affecting both kidneys, or who have one-sided hydronephrosis but do not meet the kidney function requirements

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