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
N/A
80 Years
Both
Bladder Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Willem Oosterlinck, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Ziekenhuis Gent
Authority:
United States: Federal Government
Study ID:
EORTC-30004
NCT ID:
NCT00042887
Start Date:
May 2002
Completion Date:
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- recurrent bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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