Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Proportion of patients undergoing selective bladder preservation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo a radical cystectomy, including pelvic lymphadenectomy,
between 4 and 6 weeks after initiating course 4 of chemotherapy.
干预措施: therapeutic conventional surgery (Procedure)
Arm II
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.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Proportion of patients undergoing selective bladder preservation
Proportion of patients undergoing radical cystectomy
Overall survival
Number of patients randomized over 3 years
次要结局
- Quality of life as assessed by the QLQ-C30 v3.0 questionnaire
- Rate of salvage cystectomy after selective bladder preservation
- Toxicity as assessed by NCI CTCAE v3.0
- Locoregional progression-free, metastasis-free, and overall survival
- Compliance with randomized treatment