Project #1: MRI-guided Bladder Cancer Preservation Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 主要终点
- Pathological complete response rate and Urinary and Rectal Toxicity
研究概览
简要总结
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders
详细描述
HYPOTHESIS The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Bladder Preservation Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation of the TURBT cavity.
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation (Noel et al., 2015). MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This is especially important in bladder tumors where bladder is subject to large interfractional position changes as well as intrafractional shape and size variation since the on-board median filling rate is close to 2 ml/min. This requires that intrafraction bladder filling has to be successfully accommodated in order to maintain adequate target coverage (Dees-Ribbers et al., 2014). It is hypothesized therefore that MRgRT facilitates tumor boost and partial bladder irradiation approaches (Hafeez et al., 2016; Vestergaard et al., 2016).
MRgRT has been shown to be feasible. Authors reported that the full online adaptive planning workflow based on the anatomy seen at each fraction was delivered within 45 min. Intra-fraction bladder filling did not compromise target coverage. Patients reported acceptable tolerance of treatment (Hunt et al., 2020).
Primary Objectives A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with T2-T3N0M0 unifocal bladder cancer of any histologic subtype except squamous cell carcinoma or adenocarcinoma (Janopaul-Naylor et al., 2021) treated the maximal TURBT and able to tolerate concurrent chemoradiotherapy. Selected patients with high risk of common iliac involvement (T4 disease and/or limited N+ disease and/or LVSI+ status) able to receive the following treatment may be included as well. Additional criteria include:
- •Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- •WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
排除标准
- •Prior radiation therapy to the target areas;
- •Inability to undergo a MRI exam
结局指标
主要结局
Pathological complete response rate and Urinary and Rectal Toxicity
时间窗: Five years
A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
次要结局
- Blood and urine biomarkers, Radiomics biomarkers and PROMs(5 years)
研究者
Rafael Martínez Monge
Scientific Director, Radiation Oncology Department
Clinica Universidad de Navarra, Universidad de Navarra