Bladder Cancer Clinical Trial
Official title:
Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
Verified date | January 2019 |
Source | Institute of Cancer Research, United Kingdom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount
of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill
tumor cells. It is not yet known whether radiation therapy is more effective than surgery in
treating patients with bladder cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
works compared with surgery in treating patients with bladder cancer who are receiving
chemotherapy.
Status | Completed |
Enrollment | 45 |
Est. completion date | April 2017 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Cancer Research - Sutton | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Institute of Cancer Research, United Kingdom |
United Kingdom,
Huddart RA, Birtle A, Maynard L, Beresford M, Blazeby J, Donovan J, Kelly JD, Kirkbank T, McLaren DB, Mead G, Moynihan C, Persad R, Scrase C, Lewis R, Hall E. Clinical and patient-reported outcomes of SPARE - a randomised feasibility study of selective bl — View Citation
Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011 Mar 15; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients randomized over 3 years | |||
Primary | Proportion of patients undergoing selective bladder preservation | |||
Primary | Proportion of patients undergoing radical cystectomy | |||
Primary | Overall survival | |||
Secondary | Compliance with randomized treatment | |||
Secondary | Rate of salvage cystectomy after selective bladder preservation | |||
Secondary | Toxicity as assessed by NCI CTCAE v3.0 | |||
Secondary | Quality of life as assessed by the QLQ-C30 v3.0 questionnaire | |||
Secondary | Locoregional progression-free, metastasis-free, and overall survival |
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