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Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
mitomycin C
conventional surgery
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Universitair Ziekenhuis Gent
  • Virga Jesse Hospital
  • U.Z. Gasthuisberg
  • Universita Di Palermo
  • Ospedale S.S. Annunziata
  • Onze Lieve Vrouwe Gasthuis
  • Academisch Medisch Centrum
  • Jeroen Bosch Ziekenhuis
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Comenius University School of Medicine
  • Dokuz Eylul University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 5, 2002
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00042887
Brief Title
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
May 2002 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mitomycin C
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem Oosterlinck, MD, PhD
Organizational Affiliation
Universitair Ziekenhuis Gent
Official's Role
Study Chair
Facility Information:
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Virga Jesse Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Universita Di Palermo
City
Palermo
ZIP/Postal Code
90141
Country
Italy
Facility Name
Ospedale S.S. Annunziata
City
Savigliano
ZIP/Postal Code
12038
Country
Italy
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
NL'S Hertogenbosch
ZIP/Postal Code
NL-5211
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Comenius University School of Medicine
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Dokuz Eylul University School of Medicine
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

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Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

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