Study Stopped
slow accrual
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
1 other identifier
interventional
190
4 countries
8
Brief Summary
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer:
- 1.A combination of bladder wall heating and local chemotherapy (Synergo)
- 2.Bacillus Calmette-Guérin (BCG)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2002
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 7, 2014
October 1, 2014
11.8 years
October 5, 2006
October 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence free survival
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
2 years
Secondary Outcomes (3)
Proportion of complete response in CIS patients
3 months
Progression rate (to disease stage>T1) and/or metastatic disease
2 years
Local and systemic side effects, both subjective and objective
2 years
Study Arms (2)
Synergo + MMC
EXPERIMENTALCombined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Bacillus Calmette-Guérin
ACTIVE COMPARATORIntravesical instillation with BCG (Bacillus Calmette-Guérin)
Interventions
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Eligibility Criteria
You may qualify if:
- Superficial TCC: Any G3 or any T1 and/or CIS
- Multifocal (\>1) Ta lesions
- Multiple recurrences (\>2) of Ta lesions in the last 24 months
- Complete tumor eradication must be confirmed
- WHO performance status 0-2 (Appendix V)
- Life expectancy of more than 24 months
- Patients willing to sign informed consent
You may not qualify if:
- Bladder tumors other than TCC
- Coexistence of another primary malignant tumor other than BCC of the skin
- TCC of the bladder involving the urethra or upper urinary tract
- Previous history of TCC stage T2 or higher
- Clinical presence or previous history of regional spreading or distant metastases
- Intravesical MMC treatments during the last 12 months
- Previous intravesical BCG therapy (Any intravesical BCG therapy in the last 24 months, or More than 6 BCG intravesical instillations in the last 48 months.
- Previous pelvic radiotherapy or systemic chemotherapy
- Partial cystectomy
- Diverticle of bladder larger than 1cm in diameter
- Residual urine \> 100cc measured by uroflowmetry
- Bladder volume \< 150cc measured by ultrasound
- Urinary incontinence (more than one wet pad a day)
- Urethral stricture impeding 20F catheterization
- Urethral bleeding or persistent hematuria
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Hospital - AKH Vienna
Vienna, Austria
Bnai Zion Medical Center
Haifa, Israel
Wolfson Hospital
Holon, Israel
Hadassah University Hospital
Jerusalem, Israel
Galliera Hospital
Genova, Italy
Istituto Europeo del Oncologia
Milan, Italy
San Raffaele Hospital (HSR)
Milan, Italy
Department of Urology, Radboud University Hospital
Nijmegen, Netherlands
Related Publications (1)
Arends TJ, Nativ O, Maffezzini M, de Cobelli O, Canepa G, Verweij F, Moskovitz B, van der Heijden AG, Witjes JA. Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guerin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non-Muscle-invasive Bladder Cancer. Eur Urol. 2016 Jun;69(6):1046-52. doi: 10.1016/j.eururo.2016.01.006. Epub 2016 Jan 20.
PMID: 26803476DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred A Witjes, MD PhD
Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2006
First Posted
October 6, 2006
Study Start
February 1, 2002
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 7, 2014
Record last verified: 2014-10