Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
18 Years
N/A
Both
Bladder Cancer
Trial Information
Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
OBJECTIVES:
Primary
- To determine the feasibility and patient acceptability of radical cystectomy vs
selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with
muscle-invasive transitional cell carcinoma of the bladder.
- To determine compliance rates of patients with their assigned treatments.
- To determine if bladder preservation is equivalent to radical cystectomy, in terms of
overall survival, in responders to neoadjuvant chemotherapy.
Secondary
- To compare the overall survival of patients receiving SBP vs radical cystectomy.
- To determine the rate of salvage cystectomy in patients undergoing bladder
preservation.
- To determine and compare the toxicity of treatment in both arms.
- To determine and compare quality of life of patients treated with these regimens.
- To compare locoregional progression-free and metastasis-free survival of patients
treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and
randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of
pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2,
macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo
completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically
normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment
according to randomization arm.
NOTE: *Patients with a clear bladder or those who are unsure of their histological results
prior to course 4 also proceed to chemotherapy.
- Course 4 of neoadjuvant chemotherapy: Patients receive gemcitabine hydrochloride IV
over 30 minutes on days 1 and 8 and cisplatin IV over 4 hours on day 1.
- Arm I (radical cystectomy): Patients undergo a radical cystectomy, including pelvic
lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
- Arm II (selective bladder preservation): Patients with no visible residual tumor (cT0
or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning
within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
Health-related quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for up to 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma (TCC) of the bladder
- Clinical stage T2-T3, N0, M0
- No widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumor
- No adenocarcinoma, squamous cell carcinoma (SCC), small cell carcinoma, or other
variant histology
- N.B. squamoid differentiation or mixed TCC/SCC allowed
- No simultaneous upper tract, urethral, or prostatic urethral TCC
- Direct prostatic urethral extension from bladder primary allowed if not
involving prostatic stroma
- Currently receiving 3 courses of gemcitabine hydrochloride-cisplatin or other
protocol approved neoadjuvant chemotherapy regimen AND willing and fit to receive a
4th course according to study protocol
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin > 10 g/dL
- WBC > 3,000/mm³
- Platelet count > 150,000/mm³
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST < 1.5 times ULN
- Alkaline phosphatase < 1.5 times ULN
- Not pregnant
- Fit for radical cystectomy or radical radiotherapy
- No prior malignancy within the past 5 years except superficial TCC or CIS
- No untreated hydronephrosis
- Patients with hydronephrosis are eligible if the kidney/ureter has been stented
or nephrostomy has been inserted and renal function has been maintained
- No contraindication to radical radiotherapy (e.g., inflammatory bowel disease,
radiosensitivity syndrome, or severe diverticular disease)
- No bilateral total hip replacements
- No significant comorbid medical conditions that would interfere with administration
of any protocol treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Number of patients randomized over 3 years
Safety Issue:
No
Principal Investigator
Robert A. Huddart, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000633526
NCT ID:
NCT00867347
Start Date:
December 2006
Completion Date:
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- stage II bladder cancer
- stage III bladder cancer
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
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