Status:

UNKNOWN

Sequential Combination Therapy in Bladder Cancer

Lead Sponsor:

Azienda Ospedaliera "Sant'Andrea"

Conditions:

Bladder Cancer

Eligibility:

MALE

30+ years

Phase:

PHASE4

Brief Summary

A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres. The subjects will be assessed for eligibility at the screening visit (Visit 1) t...

Detailed Description

Methods: A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres Clinical evaluation: Patients with High Risk Non-Muscle Invasive Blad...

Eligibility Criteria

Inclusion

  • Patients with high risk non muscle invasive bladder cancer
  • High risk of progression (EORTC risk score \> 6)
  • Males
  • Signature of Informed Consent
  • Ability of consent

Exclusion

  • Low Risk Non-Muscle Invasive Bladder Cancer
  • Muscle Invasive Bladder Cancer
  • Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract
  • Previous bladder or prostate surgery
  • Prostate or bladder radiotherapy
  • Urinary tract infection
  • Chronic urinary retention or indwelling catheters
  • Neurological patients
  • Previous BCG infections
  • Previous or current chemotherapy for other kind of cancers
  • Patients older than 75
  • WHO performance status 3-4
  • Residual tumour on re-TURB

Key Trial Info

Start Date :

January 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 15 2021

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT03790384

Start Date

January 15 2019

End Date

January 15 2021

Last Update

December 31 2018

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