S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or S… (NCT00045630) | Clinical Trial Compass
CompletedPhase 2
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
United States77 participantsStarted 2003-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder
* Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed
* The following diagnoses are not allowed:
* Small cell carcinoma
* Sarcomatoid components
* Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present
* Residual disease after second TURBT allowed
* No more than 14-56 days after second TURBT
* No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis
* Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* White blood cell count (WBC) at least 3,500/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least lower limit of normal
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal
Renal
* Creatinine no greater than 2.0 mg/dL AND/OR
* Creatinine clearance at least 60 mL/min
Other
* No prohibitive medical risk that would preclude radical cystectomy
* No other serious concurrent systemic disorder that would preclude study compliance
* No …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
Timeframe: up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )