Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042887
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

August 5, 2002
January 27, 2003
September 24, 2012
May 2002
May 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00042887 on Archive Site
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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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Bladder Cancer
  • Drug: mitomycin C
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2004   (Final data collection date for primary outcome measure)


  • 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



  • 80 and under

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


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  • 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


Biologic therapy

  • More than 12 months since prior BCG vaccine


  • At least 1 year since prior mitomycin

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy


  • No prior organ transplant


  • At least 3 months since prior intravesical treatment
Sexes Eligible for Study: All
up to 80 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Netherlands,   Slovakia,   Turkey
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Willem Oosterlinck, MD, PhD Universitair Ziekenhuis Gent
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP