NCT02240017

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Urothelial Cancer
• Metastatic Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.
DRUG	Fractionated Cisplatin	Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.
DRUG	Gemcitabine	Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.

Timeline

• Start date: 2015-01-21
• Primary completion: 2018-04-10
• Completion: 2019-07-15
• First posted: 2014-09-15
• Last updated: 2019-08-09

Locations

18 sites across 1 country: France