Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
This study has been terminated.
(low accrual)
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00042887
First received: August 5, 2002
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: mitomycin C Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Mitomycin
U.S. FDA Resources
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
| Enrollment: | 58 |
| Study Start Date: | May 2002 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042887
Locations
| Belgium | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Virga Jesse Hospital | |
| Hasselt, Belgium, 3500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Italy | |
| Universita Di Palermo | |
| Palermo, Italy, 90141 | |
| Ospedale S.S. Annunziata | |
| Savigliano, Italy, 12038 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Jeroen Bosch Ziekenhuis | |
| NL'S Hertogenbosch, Netherlands, NL-5211 | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Slovakia | |
| Comenius University School of Medicine | |
| Martin, Slovakia, 03659 | |
| Turkey | |
| Dokuz Eylul University School of Medicine | |
| Izmir, Turkey, 35340 | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Willem Oosterlinck, MD, PhD | Universitair Ziekenhuis Gent |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00042887 History of Changes |
| Other Study ID Numbers: | EORTC-30004, EORTC-30004 |
| Study First Received: | August 5, 2002 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Mitomycins Mitomycin |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on May 16, 2013