NCT00002490

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1991

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

June 1, 2001

First QC Date

November 1, 1999

Last Update Submit

December 17, 2013

Conditions

Bladder Cancer

Keywords

stage I bladder cancertransitional cell carcinoma of the bladder

Interventions

BCG vaccineBIOLOGICAL
mitomycin CDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of transitional cell carcinoma of the bladder * Stage T1 Nx M0, grade 3 disease * No muscle invasion at base of tumor * Diagnosis of this stage made within the past 6 months * Earlier diagnosis of tumors with lower stage or grade allowed * No history of higher stage urothelial tumors * Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed * No widespread CIS causing severe symptoms * Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required * Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies PATIENT CHARACTERISTICS: Age: * Any age Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior adjuvant treatment with intravesical BCG Chemotherapy: * No more than 1 prior adjuvant treatment with intravesical chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics * Diathermic removal of associated small papillary growths allowed

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

Sponsors & Collaborators

Study Sites (1)

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Related Publications (1)

  • Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.

    RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG VaccineMitomycinRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTherapeutics

Study Officials

  • Stephen J. Harland, MD

    University College London Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1991

Last Updated

December 18, 2013

Record last verified: 2001-06

Locations

GB(1)