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Clinical Trial Summary

This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included.

Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm:

- Fractionated Cisplatin + Gemcitabine.

- Carboplatin + Gemcitabine.

The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02240017
Study type Interventional
Source Institut Claudius Regaud
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 21, 2015
Completion date July 15, 2019

See also
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