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

NCT02240017 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-08-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Loic MOUREY, MD · Institut Claudius Regaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-21
Primary Completion
2018-04-10
Completion
2019-07-15

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240017 on ClinicalTrials.gov