NCT04139967终止不适用
Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of participants who experience a grade 2 adverse event
研究概览
简要总结
This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years or older at time of diagnosis
- •No restrictions on gender or ethnicity
- •Ability and willingness to make follow up appointments
- •Pathologic diagnosis of rectal cancer
- •Presentation could be symptomatic or asymptomatic
- •T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis
- •Peri-rectal node positive allowed
- •Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery
- •Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology
- •Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule
排除标准
- •Age under 70 years of age
- •Ability and desire to receive definitive surgical intervention
- •Ability and desire to receive concurrent chemoradiation therapy
结局指标
主要结局
Number of participants who experience a grade 2 adverse event
时间窗: week 5
CTCAE V4.0 will be used to determine the grade 2 AE.
Progression-free survival
时间窗: 5 years
Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
次要结局
- Number of participants who received surgery for their cancer(5 years)
- Number of participants with improved symptoms(5 years)
- Number of participant who experience metastatic disease(5 years)
- Change in Mean quality of life(baseline to 24 months)
- Change in Mean functional status(baseline to 24 months)
研究者
Haoming (Carl) Qiu
Associate Professor
University of Rochester
研究点 (2)
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