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Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2004 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on August 5, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer - EORTC
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042887
  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 III

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
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Mitomycin Mitomycins
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
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.

  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 Organization for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Willem Oosterlinck, MD, PhD Universitair Ziekenhuis Gent
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00042887     History of Changes
Other Study ID Numbers: CDR0000069482, EORTC-30004
Study First Received: August 5, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 February 13, 2012



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