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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT01104350
Eligibility Criteria:
Inclusion Criteria:
* MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
* Karnofsky Performance Scale (KPS) ≥ 70%
* Age ≥18 years old
* Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
* Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
* Adequate renal function: calculated creatinine clearance \> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
* Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
* Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
* Previous pelvic radiation therapy
* Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
* Prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles
* Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
* Women who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01104350
Study Brief:
Protocol Section:
NCT01104350