MRI-guided Rectal 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
- 32
- 主要终点
- Total Mesorectal Excision (TME)-free survival
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 rectal preservation
详细描述
HYPOTHESIS
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a TNT Program renders improved TME-free rates due to the better visualization and online dose-adaptation of the Gross Tumor Volume (GTV).
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. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen. This is especially important in rectal cancer where the rectum is subject to interfractional position changes, volume shrinkage and intrafractional shape and size variation due to the variability in rectal filling.
Primary Objectives
A. To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older with primary Stage II (T3-4, N0) or Stage III (any T, N1-2) biopsy-proven rectal cancer
- •No prior radiation therapy to the target areas;
- •ECOG 0-2 with medical status not contraindicating treatment with radical intent including TNT and TME (if required) and with basal laboratory values as follows:
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- •Platelets ≥ 50,000 cells/mm
- •Hemoglobin ≥ 8.0 g/dl.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 4 x upper limit of normal.
- •Total bilirubin < 2 x upper normal mg/dL.
- •Alkaline phosphatase < 4 x upper limit of normal.
排除标准
- •Patient unable to undergo an MRI examination
结局指标
主要结局
Total Mesorectal Excision (TME)-free survival
时间窗: 5-years
To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
次要结局
- Proctitis/Rectal Bleeding(5-years)
- Fecal Continence(5-years)