Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
NCT ID: NCT01801644
Last Updated: 2013-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2007-04-30
2013-02-28
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine plus cisplatin
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
gemcitabine plus cisplatin
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
Interventions
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gemcitabine plus cisplatin
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* bone marrow reserve (neutrophil count \>1500 cells per μL,platelet count \>100 000 per μL) count
* hepatic function (serum bilirubin \<2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
* renal function with a creatinine clearance \>60ml/min
Exclusion Criteria
* serious or uncontrolled concurrent medical illness
* pregnancy
* history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
* non-transitional cell bladder cancer
* creatinine clearance \<60ml/min
18 Years
ALL
No
Sponsors
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Barmherzige Brüder Vienna
OTHER
Responsible Party
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Johannes Meran
Prof. Dr.Johannes Meran
Principal Investigators
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Johannes Meran, M.D.
Role: PRINCIPAL_INVESTIGATOR
Barmherzige Brüder Vienna
Locations
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Barmherzige Brüder Vienna
Vienna, Vienna, Austria
Countries
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References
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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.
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)
Other Identifiers
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Bladder Cancer-001
Identifier Type: OTHER
Identifier Source: secondary_id
Bladder Cancer-001
Identifier Type: -
Identifier Source: org_study_id
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