Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Barmherzige Brüder Vienna

Status: Completed

Conditions: Bladder Cancer

Treatments: Drug: gemcitabine plus cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01801644

Bladder Cancer-001 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

gemcitabine plus cisplatin

Experimental group

Description:

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

Treatment:

Drug: gemcitabine plus cisplatin