Neoadjuvant Chemo (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer

The Evaluation of Efficacy and Toxicity of Combined Treatment: Neoadjuvant Chemotherapy (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer Stage T2b-T3 NO/Nx M0

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490880

Enrollment

Registered

2007-06-25

Start date

2003-11-30

Completion date

2004-08-31

Last updated

2007-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief summary

The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with either radical cystectomy or radiotherapy in the treatment of bladder cancer.

Interventions

DRUGgemcitabine

DRUGcisplatin

PROCEDUREradical cystectomy

PROCEDUREradiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0. * Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy. * Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm.

Exclusion criteria

* Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix) * PSA greater than 5.0 ng/mL * Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.

Design outcomes

Primary

Measure	Time frame
To evaluate efficacy	—

Secondary

Measure	Time frame
To evaluate pathological complete responses	—
To evaluate progression free survival	—
To evaluate overall survival	—
To evaluate time to disease progression	—
To evaluate safety	—

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026