Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

This study has been terminated.
(low accrual)
Sponsor:
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
  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:


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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014