Completed

VEFORARandomized, 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.

What is being tested

Carboplatin

+ Gemcitabine

+ Fractionated Cisplatin

Drug

Who is being recruted

Over 18 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: January 2015

See protocol details

Summary

Principal SponsorInstitut Claudius Regaud

Last updated: January 27, 2026

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Study start date: January 21, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleRandomized, 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.

NCT02240017

Principal SponsorInstitut Claudius Regaud

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

15 inclusion criteria required to participate

Age <= 18 years, patients aged 75 years or more will benefit from a geriatric assessment.

Advanced or metastatic urothelial cancer confirmed histologically or cytologically.

Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma.

Measurable disease according to RECIST criteria V1.1.

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12 exclusion criteria prevent from participating

Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ).

Pregnant or lactating women.

Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations.

Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin

Angers, FranceOpen INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin in Google Maps

Suspended

Chru Besancon - Hopital Jean Minjoz

Besançon, France

Suspended

Institut Bergonie

Bordeaux, France

Suspended

Centre Francois Baclesse

Caen, France

Completed18 Study Centers