NCT00042887

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Geographic Reach
5 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

August 5, 2002

Last Update Submit

September 20, 2012

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancerrecurrent bladder cancertransitional cell carcinoma of the bladder

Interventions

mitomycin CDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Universita Di Palermo

Palermo, 90141, Italy

Location

Ospedale S.S. Annunziata

Savigliano, 12038, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Jeroen Bosch Ziekenhuis

NL'S Hertogenbosch, NL-5211, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Comenius University School of Medicine

Martin, 03659, Slovakia

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Willem Oosterlinck, MD, PhD

    University Ghent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Primary Completion

May 1, 2004

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

SL(1)TU(1)BE(4)NL(4)IT(2)