Bladder Cancer Clinical Trial
Official title:
A Multicenter, Randomized Phase II Trial of Vinflunine/Gemcitabine vs Carboplatin/Gemcitabine as First Line Treatment in Patients With Metastatic Urothelial Carcinoma Unfit for Cisplatin Based Chemotherapy Due to Impaired Renal Function.
This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.
Rational The standard first line treatment for patients with metastatic urothelial carcinoma
unfit for cisplatin due to renal impairment is carboplatin containing chemotherapy, with a
median overall survival of approximately 8-10 month. New, more effective regimens in terms of
tumor control and quality of life are urgently needed. Vinflunine has proven efficacy in
urothelial carcinoma and is registered as second line treatment. The combination of
gemcitabine and vinflunine has not yet been evaluated in first line treatment for patients
with metastatic urothelial carcinoma.
Objectives
- To compare the progression free survival (FPS) of vinflunine/gemcitabine versus
carboplatin/gemcitabine in patients with locally advanced or metastatic transitional
cell carcinoma of the urothelial tract unfit for cisplatin based chemotherapy due to
impaired renal function.
- To evaluate the tumour response (ORR), overall survival (OS) and disease control rate
(DCR) of vinflunine/gemcitabine versus carboplatin/gemcitabine
- To assess the safety and toxicity of vinflunine/gemcitabine versus
carboplatin/gemcitabine.
- To investigate and compare Quality of life during treatment with vinflunine/gemcitabine
and carboplatin/gemcitabine respectively.
;
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