Clinical trial NCT01801644: Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
Official title: Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
neoadjuvant chemotherapy
gem/cis
Lead sponsor: Barmherzige Brüder Vienna
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* 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:

* metastatic disease
* 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

Primary outcomes:
measure: pathologic response rate
timeFrame: at time of surgery
Secondary outcomes:
measure: safety, number of participants with adverse events and grade of adverse events
timeFrame: adverse events will be evaluated after every 6 months
Other outcomes:
measure: progression free survival (PFS)
timeFrame: up to 5 years after including the last patient
Locations:
city: Vienna
country: Austria
facility: Barmherzige Brüder Vienna
Study officials:
affiliation: Barmherzige Brüder Vienna
name: Johannes Meran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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)