Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003175




Registration number
NCT00003175
Ethics application status
Date submitted
1/11/1999
Date registered
30/04/2004
Date last updated
4/12/2013

Titles & IDs
Public title
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
Scientific title
A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
Secondary ID [1] 0 0
MRC-BA10
Secondary ID [2] 0 0
CDR0000065985
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Transitional Cell Cancer of the Renal Pelvis and Ureter 0 0
Urethral Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Kidney
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent locally advanced or metastatic transitional cell urinary tract carcinoma that has been previously untreated with systemic chemotherapy Pelvic relapse after radiotherapy or surgery No relapse solely within a previously irradiated field Nodal or metastatic disease Lesions within the abdomen or pelvis must be assessed using CT scanning At least one site of disease must be previously unirradiated and assessable for response Bone metastases cannot be used as an indicator lesion Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Glomerular filtration rate at least 50 mL/min Creatinine clearance at least 25 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Rio Grande do Sul
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amsterdam
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
Norway
State/province [7] 0 0
Oslo
Country [8] 0 0
South Africa
State/province [8] 0 0
Cape Town
Country [9] 0 0
United Kingdom
State/province [9] 0 0
England
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Northern Ireland
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Scotland
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Wales
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Government body
Name
Medical Research Council
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.
Trial website
https://clinicaltrials.gov/study/NCT00003175
Trial related presentations / publications
Highley MS, Griffiths GO, Uscinska BM, Huddart RA, Barber JB, Parmar MK, Harper PG; NCRI Bladder Cancer Clinical Studies Group. A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract. Clin Oncol (R Coll Radiol). 2009 Jun;21(5):394-400. doi: 10.1016/j.clon.2009.01.011. Epub 2009 Mar 9.
Highly M, Griffiths G, Uscinska B, et al.: A phase II trial of continous 5-fluorouracil (5-FU) in recurrent locally advanced or metastatic transitional cell of the urinary tract. Br J Cancer 85(suppl 1): A-P77, 52, 2001.
Public notes

Contacts
Principal investigator
Name 0 0
Peter G. Harper, MD
Address 0 0
St. Thomas' Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00003175