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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03617003
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC
* Residual or recurrent cancer following prior endoscopic treatment
* Ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter.
* Karnofsky performance status ≥ 50%
* Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. Demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days.
* Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment
* Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2)
* Adequate organ function defined at baseline as:
* ANC ≥1,000/ µL
* Platelets ≥75,000/ µL
* Hb ≥9 g/dl
* INR ≤1.5 (except for patients who are on full-dose warfarin)
* Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault method)
* Total serum bilirubin ≤1.5 mg/dL
* AST/ALT ≤5× upper limit of normal
* Able to provide written informed consent
Exclusion Criteria:
* Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include:
* Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months)
* Women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 mIU/ml
* Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence or where the partner is sterile
* T4 tumors with involvement of the bowel or major blood vessels • Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease that, in the opinion of the study investigator, would make the patient a poor candidate for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03617003
Study Brief:
Protocol Section:
NCT03617003