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| ID | Type | Description | Link |
|---|---|---|---|
| Bladder Cancer-001 | Other Identifier | Barmherzige Brüder, Austria |
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To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.
Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.
Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.
Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine plus cisplatin | Experimental | gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine plus cisplatin | Drug | gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathologic response rate | evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy | at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| safety, number of participants with adverse events and grade of adverse events | to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer | adverse events will be evaluated after every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival (PFS) | pfs will be assessed avery 3 months in the first year after radical cystectomy, every 6 months in the second year, and yearly from the 3rd year up to a minimum follow up of 5 years | up to 5 years after including the last patient |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Meran, M.D. | Barmherzige Brüder Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barmherzige Brüder Vienna | Vienna | State of Vienna | 1020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18823036 | Background | Dash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848. | |
| Result | Tolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; Barmherzige Brueder Hospital, Vienna, Austria; Goettlicher Heiland Hospital, Vienna, Austria ´ J Clin Oncol 29: 2011 (suppl 7; abstr 296) |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |