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Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)

NCT01675219 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-04-13

No results posted yet for this study

Summary

Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs.

The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.

Conditions

Interventions

PROCEDURE

white light TUR-BT

traditional transurethral bladder tumor resection

PROCEDURE

blue light TUR-BT

photodynamic transurethral bladder tumor resection

DRUG

optimized MMC

six weekly optimized mitomycin-C instillations

DRUG

single immediate chemotherapy instillation

single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation

Sponsors & Collaborators

  • Finnbladder

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Peter J. Boström, MD, PhD · Turku University Hospital

  • Eero Kaasinen, Md, PhD · Hyvinkää District Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2021-12-31
Completion
2023-08-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

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 NCT01675219 on ClinicalTrials.gov