Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
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:	Treatment, Randomized, Active Control
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 Surgery

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
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Virga Jesse Hospital
Hasselt, Belgium, 3500
Italy
Ospedale S.S. Annunziata
Savigliano, Italy, 12038
Universita Di Palermo
Palermo, Italy, 90141
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
Jeroen Bosch Ziekenhuis
NL'S Hertogenbosch, Netherlands, NL-5211
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
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

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

Study ID Numbers:	CDR0000069482, EORTC-30004
Study First Received:	August 5, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00042887 History of Changes
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

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Mitomycins

Recurrence
Carcinoma
Anti-Bacterial Agents
Urologic Diseases
Mitomycin
Bladder Neoplasm
Alkylating Agents
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Antibiotics, Antineoplastic
Mitomycins

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 10, 2009