Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

• Sponsor: Medical Enterprises Europe B.V. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00384891
• Collaborator: (none)
• Enrollment: 190
• Locations: 8
• Arms: 2
• Duration (Months): 142
• Patients Per Site: 23.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Diseases; Urinary Bladder Neoplasms; Urinary Bladder Cancer; Malignant Tumor of Urinary Bladder; Urologic Diseases; Urologic Neoplasms; Neoplasms; Neoplasms by Site	Device: Synergo + MMC; Drug: Bacillus Calmette-Guérin	Phase 3

Detailed Description

The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer.

Patients must have their tumors surgically resected prior to study enrollment, and undergo a series of tests to prove their bladder is now free of tumor. Eligible patients will be randomly assigned to one of 2 treatment arms:

1. A combination of bladder wall heating and local chemotherapy (Synergo)

2. Bacillus Calmette-Guérin (BCG)

Patients will be treated during the first year of the study, and will be followed up for a total of 2 years. The follow up will include a visual evaluation of the patient's bladder by cystoscopy, a cytological examination of the urine (to look for malignant cells) and other additional exams. The patients' general welfare will be monitored through out the study.

The aim of this study is to compare the efficacy and safety of the novel treatment (Synergo) to that of the well-known BCG

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: Feb 1, 2002
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Synergo + MMC Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C	Device: Synergo + MMC; Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C; Other Names: RITE SHTC
Active Comparator: Bacillus Calmette-Guérin Intravesical instillation with BCG (Bacillus Calmette-Guérin)	Drug: Bacillus Calmette-Guérin; Intravesical instillation with BCG (Bacillus Calmette-Guérin); Other Names: BCG

Outcome Measures

Primary Outcome Measures

1. Recurrence free survival [2 years]

   Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor

Secondary Outcome Measures

1. Proportion of complete response in CIS patients [3 months]

2. Progression rate (to disease stage>T1) and/or metastatic disease [2 years]

3. Local and systemic side effects, both subjective and objective [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Active intractable or uncontrollable UTI

• Active tuberculosis or BCG infection

• Patients who experienced BCG life threatening sepsis

• Known allergy to MMC or BCG

• Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy

• Hematological disorders; leukocytes < 3500, platelets < 100,000

• Kidney or liver function disorders (more than 1.5 times upper normal limit)

• Pregnant or lactating women

• Patients who cannot be followed up properly or are unable to collaborate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital - AKH Vienna	Vienna		Austria
2	Bnai Zion Medical Center	Haifa		Israel
3	Wolfson Hospital	Holon		Israel
4	Hadassah University Hospital	Jerusalem		Israel
5	Galliera Hospital	Genova		Italy
6	Istituto Europeo del Oncologia	Milan		Italy
7	San Raffaele Hospital (HSR)	Milan		Italy
8	Department of Urology, Radboud University Hospital	Nijmegen		Netherlands

Sponsors and Collaborators

• Medical Enterprises Europe B.V.

Investigators

• Principal Investigator: Alfred A Witjes, MD PhD, Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical Enterprises Europe B.V.
• ClinicalTrials.gov Identifier: NCT00384891
• Other Study ID Numbers: 102.1
• First Posted: Oct 6, 2006
• Last Update Posted: Oct 7, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Medical Enterprises Europe B.V.: Superficial urothelial cell carcinoma of bladder; NMIBC; Non Muscle Invasive Bladder Cancer; Hyperthermia; Bladder instillation; Mitomycin C; RITE; SHTC; Intravesical
• Additional relevant MeSH terms: Neoplasms; Urinary Bladder Neoplasms; Neoplasms by Site; Urologic Neoplasms; Urologic Diseases; Urinary Bladder Diseases; Hyperthermia; Fever; BCG Vaccine

Study Results

No Results Posted as of Oct 7, 2014