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

Primary Purpose

Bladder Cancer

Status
Active
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
white light TUR-BT
blue light TUR-BT
optimized MMC
single immediate chemotherapy instillation
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Primary papillary bladder cancer at high risk for further recurrence as defined as follows:

Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors

  • Histologically proven Ta bladder cancer
  • Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
  • Written informed consent is required from every eligible patient

Exclusion Criteria:

  • Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
  • CIS (carcinoma in situ)
  • Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
  • Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
  • Suspicion or previous history of the patient not tolerating intravesical instillations
  • Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
  • Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
  • Pregnancy or lactating patient
  • Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years)
  • Age < 18 years
  • Expected survival time less than one year
  • Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)

Sites / Locations

  • HYKS Peijas Hospital
  • Hyvinkää District Hospital
  • Kuopio University Hospital
  • Mikkeli Central Hospital
  • Oulu University Hospital
  • Satakunnan keskussairaala
  • Seinäjoki Central Hospital
  • Hatanpään sairaala
  • Tampere University Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Group B

Group A

Group C

Group D

Arm Description

Blue light TUR-BT with no adjuvant instillations

White light TUR-BT with no adjuvant instillations

White light TUR-BT with six weekly optimized mitomycin-C instillations.

Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.

Outcomes

Primary Outcome Measures

bladder cancer recurrence rate
any bladder cancer recurrence at 2 years.

Secondary Outcome Measures

Bladder cancer progression
bladder cancer progression to T2 or higher
Treatment failure
progression, recurrence or side effects preventing completing the trial
mortality
death due bladder cancer or other reasons

Full Information

First Posted
August 25, 2012
Last Updated
April 11, 2023
Sponsor
Turku University Hospital
Collaborators
Finnbladder
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1. Study Identification

Unique Protocol Identification Number
NCT01675219
Brief Title
Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
Official Title
Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Finnbladder

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Experimental
Arm Description
Blue light TUR-BT with no adjuvant instillations
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
White light TUR-BT with no adjuvant instillations
Arm Title
Group C
Arm Type
Experimental
Arm Description
White light TUR-BT with six weekly optimized mitomycin-C instillations.
Arm Title
Group D
Arm Type
Experimental
Arm Description
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention Type
Procedure
Intervention Name(s)
white light TUR-BT
Intervention Description
traditional transurethral bladder tumor resection
Intervention Type
Procedure
Intervention Name(s)
blue light TUR-BT
Intervention Description
photodynamic transurethral bladder tumor resection
Intervention Type
Drug
Intervention Name(s)
optimized MMC
Other Intervention Name(s)
optimized mitomycin-C
Intervention Description
six weekly optimized mitomycin-C instillations
Intervention Type
Drug
Intervention Name(s)
single immediate chemotherapy instillation
Other Intervention Name(s)
single instillation
Intervention Description
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Primary Outcome Measure Information:
Title
bladder cancer recurrence rate
Description
any bladder cancer recurrence at 2 years.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bladder cancer progression
Description
bladder cancer progression to T2 or higher
Time Frame
2 years
Title
Treatment failure
Description
progression, recurrence or side effects preventing completing the trial
Time Frame
2 years
Title
mortality
Description
death due bladder cancer or other reasons
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
costs
Description
For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Primary papillary bladder cancer at high risk for further recurrence as defined as follows: Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors Histologically proven Ta bladder cancer Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer Written informed consent is required from every eligible patient Exclusion Criteria: Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system) CIS (carcinoma in situ) Suspicion or evidence of papillary tumors or CIS of the upper urinary tract Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer Suspicion or previous history of the patient not tolerating intravesical instillations Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®) Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician) Pregnancy or lactating patient Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years) Age < 18 years Expected survival time less than one year Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Boström, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eero Kaasinen, Md, PhD
Organizational Affiliation
Hyvinkää District Hospital
Official's Role
Study Director
Facility Information:
Facility Name
HYKS Peijas Hospital
City
Helsinki
Country
Finland
Facility Name
Hyvinkää District Hospital
City
Hyvinkää
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Mikkeli Central Hospital
City
Mikkeli
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Satakunnan keskussairaala
City
Pori
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Hatanpään sairaala
City
Tampere
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

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

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