- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042887
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder.
- Compare the disease-free survival of patients treated with these regimens.
- Determine the response rate at 6 weeks in patients treated with chemoresection.
- Determine the percent of patients with tumor at 6 weeks treated with transurethral resection.
- Compare the quality of life of patients treated with these regimens.
- Compare the side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks.
- Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin.
Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6.
Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brussels, Belgium, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Ghent, Belgium, B-9000
- Universitair Ziekenhuis Gent
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Hasselt, Belgium, 3500
- Virga Jesse Hospital
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Palermo, Italy, 90141
- Università di Palermo
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Savigliano, Italy, 12038
- Ospedale S.S. Annunziata
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum
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Amsterdam, Netherlands, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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NL'S Hertogenbosch, Netherlands, NL-5211
- Jeroen Bosch Ziekenhuis
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Rotterdam, Netherlands, 3008 AE
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
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Martin, Slovakia, 03659
- Comenius University School of Medicine
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Izmir, Turkey, 35340
- Dokuz Eylul University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder
- Ta or T1
- Tumor no greater than 2 cm in diameter
- Negative urine cytology
- No suspicious lesions in bladder requiring biopsy
- No tumors in the prostatic urethra or upper urinary tract
- No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ
PATIENT CHARACTERISTICS:
Age
- 80 and under
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- HIV negative
- No active intractable or uncontrollable bladder infection
- No urethral strictures that would preclude endoscopic procedures or repeated catheterization
- No prior or concurrent congenital or acquired immune deficiency syndrome
- No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix
- No prior or concurrent leukemia or Hodgkin's disease
- No concurrent disease for which general anesthesia is contraindicated
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 12 months since prior BCG vaccine
Chemotherapy
- At least 1 year since prior mitomycin
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior organ transplant
Other
- At least 3 months since prior intravesical treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: Willem Oosterlinck, MD, PhD, Universitair Ziekenhuis Gent
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Alkylating Agents
- Antibiotics, Antineoplastic
- Mitomycins
- Mitomycin
Other Study ID Numbers
- EORTC-30004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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