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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00238420
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder
* Histologic evidence of muscularis propria invasion
* Meets 1 of the following stage criteria:
* Stage T2-4a; NX, N0, or N1; and M0 disease
* Clinical stage T1, grade 3/3 disease AND requires definitive local therapy
* Tumor involvement of the prostatic urethra allowed provided the following criteria are met:
* Tumor was visibly completely resected
* No evidence of stromal invasion of the prostate
* No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration
* No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration
* Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping
* Sufficient tumor tissue available for HER2/neu analysis
* Not a candidate for radical cystectomy
* Performance status - Zubrod 0-2
* Absolute neutrophil count \>= 1,800/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8.0 g/dL (transfusion or other intervention allowed)
* Bilirubin \< 2.0 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 times upper limit of normal
* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Creatinine =\< 3.0 mg/dL
* Left ventricular ejection fraction (LVEF) \>= 40% by multigated acquisition scan (MUGA) scan or echocardiogram
* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* No transmural myocardial infarction within the past 6 months
* Not pregnant or nursing
* No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab \[Herceptin®\])
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* Able to tolerate systemic chemotherapy and pelvic radiotherapy
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* No history of allergic reaction to study drugs
* No history of inflammatory bowel disease
* No acute bacterial or fungal infection requiring IV antibiotics
* No AIDS
* No other severe active comorbidity
* No prior systemic chemotherapy with anthracyclines or taxanes
* No prior systemic chemotherapy for TCC
* No prior pelvic radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00238420
Study Brief:
Protocol Section:
NCT00238420