NCT01124682Unknown1 期
Image Guided Dose Escalated Adaptive Bladder Radiotherapy
Institute of Cancer Research, United Kingdom2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum-tolerated dose
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of external-beam radiotherapy delivered as a tumor boost in patients who have undergone prior transurethral bladder resection for muscle-invasive carcinoma of the bladder.
Secondary
- To document progression-free survival and overall survival of these patients.
- To evaluate patterns of recurrence and bladder preservation rates following dose-escalated radiotherapy in these patients.
- To determine the impact of acute and late toxicity on quality of life in these patients.
- To assess the use of gold seeds for tumor boost delineation in these patients.
- To evaluate the use of virtual cystoscopy tumor localization in these patients.
- To assess coverage of the phase II radiotherapy boost volume on the daily cone-beam images.
- To assess coverage of the phase III radiotherapy volume on cone-beam images with selected adaptive strategy.
- To evaluate the use of diffusion-weighted MRI (dwMRI) scans in assessing response to radiotherapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive bladder carcinoma, including the following cellular types:
- •Adenocarcinoma
- •Transitional cell carcinoma
- •Squamous cell carcinoma
- •Clinical stage G1-3, pT2a-4 disease
- •Localized disease
- •No bone or visceral metastases
- •No lymph node metastases
- •Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Hemoglobin > 10 g/dL
- •WBC > 3,000/mm^3
- •Platelet count > 150,000/mm^3
- •Creatinine < 120 μmol/L
- •Bilirubin < 1.5 times upper limit normal (ULN)
- •AST < 1.5 times ULN
- •Alkaline phosphatase < 1.5 times ULN
- •Not pregnant
- •No inflammatory bowel disease or other significant small bowel disease
- •Physically fit for radical radiotherapy
- •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •No other malignancy within the past 2 years except adequately treated basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri
- •Prior superficial transitional cell carcinoma of the bladder allowed
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior pelvic surgery
- •No bilateral hip replacements compromising accurate radiotherapy planning
- •No prior radiotherapy to the pelvis
排除标准
- 未提供
结局指标
主要结局
Maximum-tolerated dose
次要结局
- Progression-free survival
- Overall survival
- Bladder preservation rates
- Acute and late toxicity and safety profile
- Quality of life
- Tumor boost volumes delineated with and without gold seeds
- Dose-volume histogram analysis of PTV2 and PTV3 coverage
- Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans
研究者
研究点 (2)
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