Status:
COMPLETED
Radiation Therapy or Surgery in Treating Patients Receiving Chemotherapy for Bladder Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
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. Givin...
Detailed Description
OBJECTIVES: Primary * To determine the feasibility and patient acceptability of radical cystectomy vs selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with muscle-inva...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00867347
Start Date
July 1 2007
End Date
April 1 2017
Last Update
January 4 2019
Active Locations (1)
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1
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5PT