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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT00055835
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
* Transitional, squamous, or mixed cell subtypes allowed
* Primary disease site must be the urinary bladder or urethra
* Disease confined to the true pelvis (T2-T4, N0-N3, M0)
* Must meet at least 1 of the following criteria:
* Nodal involvement at or below the level of the bifurcation of the iliac vessels
* Medically or surgically inoperable
* Patient refused cystectomy
* Measurable or nonmeasurable disease
* Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
* No extrapelvic metastases
* Eligible to receive radiotherapy
* Planned radiotherapy at a SWOG-approved facility
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least lower limit of normal
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
Renal
* Creatinine clearance at least 60 mL/min OR
* Creatinine no greater than ULN
Gastrointestinal
* No chronic diarrhea
* No malabsorption
* No extensive diverticular disease of the colon
* No inflammatory bowel disease
* No other pre-existing gastrointestinal disorders
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active infections requiring antibiotics
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis
* No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago
* No prior carboplatin
* No prior paclitaxel
* No prior gemcitabine
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior pelvic radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00055835
Study Brief:
Protocol Section:
NCT00055835