Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT04398368
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of localized (clinical American Joint Committee on Cancer \[AJCC\] stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter
* Plan to undergo RNU
* Creatinine \< 2.2 mg/dL (194 mmol/L)
* Hemoglobin \> 9 g/dL
* White blood cell count \>= 3000/uL
* Platelet count \> 75,000/uL and \< 500,000/uL
* Serum bilirubin levels below 2 times the institution's upper limits of normal
* Alkaline phosphatase levels below 2 times the institution's upper limits of normal
* Aspartate aminotransferase levels below 2 times the institution's upper limits of normal
* Alanine aminotransferase levels below 2 times the institution's upper limits of normal
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
* Suitable candidate for surgery at the discretion of the investigator
* Patient must be capable of giving appropriate approved informed consent or have an appropriate representative available to do
* Patient with a prior malignancy allowed if adequately treated \> 3 years ago with no current evidence of disease
* Women of childbearing potential (WOCBP) must have a negative pregnancy urine test within 28 days of registration, and be using an adequate method of contraception to avoid pregnancy prior to and for at least 6 months after gemcitabine instillation to minimize the risk of pregnancy
* Male patient who has a partner that is a WOCBP must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) and should avoid conceiving children prior to and for 6 months following gemcitabine instillation
Exclusion Criteria:
* Pure non-urothelial histology; urothelial carcinoma with differentiation allowed
* Evidence of nodal or distant metastases; enlarged retroperitoneal lymph nodes \> 2 cm or histologically positive lymph nodes
* History of UC of the bladder within 12 months preceding RNU, or receipt of intravesical therapy within 6 months
* History of or current prostatic urethral, urethral, or contralateral upper tract UC
* Planned radical cystectomy at time of RNU
* Symptomatic urinary tract infection of bacterial cystitis (once satisfactorily treated, patients can enter the study)
* Patient with any current malignancy except for basal or squamous cell skin cancers, noninvasive cancer of the cervix, or any other cancer deemed to be of low-risk for progression or patient morbidity during the trial period (i.e. Gleason 6 prostate cancer, renal mass \< 3 cm)
* Women who are pregnant or breastfeeding
* Prisoners or subjects who are involuntarily incarcerated
* Inability for adequate follow-up, including concerns for patient compliance or geographic proximity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04398368
Study Brief:
Protocol Section:
NCT04398368