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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01031420
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed urothelial carcinoma of bladder, ureter, or renal pelvis. T2-T4 and muscle invasion must be established by TURBT. Upper tract must be high grade. N0-N1 are eligible.
* candidate for radical cystectomy, nephroureterectomy, or segmental ureterectomy with goal of cure.
-\>/= 18 years old
* ECOG performance status 0-1.
* Adequate marrow and organ function.
* May enter on therapeutic anticoagulation if it can be safely held during perioperative period.
* No women of childbearing potential, pregnant or breastfeeding.
* LVEF \>/= 50 %
* Patients with history of other non-urothelial malignancies may enroll if: 1)no evidence of distant disease w/in last year. 2)No anticancer treatment for \>/= 1 year other than adjuvant treatment or treatment for secondary prevention. 3) Less than 360 mg/m2 lifetime dose of adriamycin.
* ability to understand and willingness to sign written informed consent and HIPAA.
Exclusion Criteria:
* Intravesicular therapy w/in 4 weeks of study entry or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier.
* Patients may not be receiving any investigational agents within 4 weeks of study entry.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy.
* Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
-. Patients who have undergone prior pelvic radiation are excluded due to risk of life threatening myelosuppression.
* Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01031420
Study Brief:
Protocol Section:
NCT01031420