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Phase Ib/II Study Assessing the Neo-adjuvant Combination Therapy of Vinflunine With Cisplatin Followed by Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer (JaNEO)

NCT02845050 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-02-13

No results posted yet for this study

Summary

Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO).

Conditions

Interventions

DRUG

Vinflunine

One cycle is defined as a period of 3 weeks of treatment: Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion Cisplatin (70 mg/m²) on Day 2, every 21 days 4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy

DRUG

Cisplatin

One cycle is defined as a period of 3 weeks of treatment: Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion Cisplatin (70 mg/m²) on Day 2, every 21 days 4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy

PROCEDURE

Radical cystectomy

max. 4 weeks after 4 cycles of neo-adjuvant treatment radical cystectomy will be performed

Sponsors & Collaborators

  • Ligartis GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02845050 on ClinicalTrials.gov