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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00734994
Eligibility Criteria:
Inclusion Criteria:
* Non-muscle invasive transitional cell carcinoma (TCC) of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with Bacillus Calmette Guerin (BCG) solution); or
* An inability to tolerate BCG
* Age \> 18
* Eastern Cooperative Oncology Group(ECOG) Performance Status 0-2
* Laboratory tests performed within 14 days of study enrollment:
* Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
* Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal \*(ULN), Asparate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Women of child bearing potential must have a negative pregnancy test
* If post-menopausal - Amenorrhea for ≥ 12 months
Exclusion Criteria:
* Pregnancy or breastfeeding
* Muscle invasive disease (T2-T4)
* Prior radiation to the pelvis
* Peripheral neuropathy (any grade)
* Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
* Known bladder fistula
* Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00734994
Study Brief:
Protocol Section:
NCT00734994