Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patient preferences for operative vs. non-operative management of rectal cancer
研究概览
简要总结
This is an observational research study. Patients with rectal cancer can choose different courses of treatment. This study will follow these patients over the course of approximately six years, depending on their treatment. Patients will be monitored through clinic visits and survey assessments to see how they do, how they feel regarding their treatment choices, and their outcomes. The surveys will analyze the impact of the patients' treatment choices, as well as patient adherence, in a rural setting.
详细描述
Standards of care for patients with rectal cancer are evolving over time. Surgery for rectal cancer is associated with significant short- and long-term side effects for patients, including changes in bowel function, self-image, ability to work, and sexual function. Emerging data indicates that some patients experiencing complete clinical response to neoadjuvant therapy (treatment given prior to surgery) may be able to forego surgery, without compromising cancer outcomes. Current National Cancer Center Network (NCCN) guidelines for the treatment of rectal cancer states that, "...the panel believes that a non-operative management approach may be considered in centers with experienced multi-disciplinary teams, after a careful discussion with the patient of his or her risk tolerance." Between 15-27% of patients achieve a complete pathological response after chemoradiotherapy (CRT), which is administered before surgery, and have low rates of local recurrence and high rates of overall survival. Treating these patients without surgery has been a focus in recent years. Supporting data is mainly from large academic institutions, which have pioneered the approach. There is very little data on this approach in rural populations. While this approach is not considered to represent the standard of care, increasing numbers of patients are choosing to pursue it. It would be useful to accumulate data on treatment of rectal cancer in a rural setting.
The study will collect and analyze data on patient preference for operative versus non-operative management, as well as patient adherence to the careful surveillance regimen required for those electing nonoperative management. In addition, patient outcomes with a focus on quality of life, as measured on a standardized tool at multiple points before, during, and after treatment will be analyzed.
Patients will undergo an initial staging evaluation, regardless of study consent, to include:
- Physical examination
- Endoscopy
- CEA, CBC, CMP
- Pelvic MRI +/- IV contrast preferred, or if MRI contraindicated, endoscopic ultrasound
- CT Chest/Abdomen/Pelvis
Patients will also complete the following survey assessments at the time of study consent:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •For a patient to be considered eligible for this study, ALL of the following conditions must be met:
- •Age 18 or greater
- •ECOG PS 0-2
- •Stage II or III, newly diagnosed, biopsy proven, rectal cancer
- •No prior treatment for rectal cancer
- •No prior pelvic radiotherapy
- •Willing to undergo study related testing and monitoring after treatment
- •Women of childbearing potential must rule out pregnancy within 2 weeks prior to registration with a blood test or urine study
- •Women must not be pregnant or breastfeeding
- •Able to provide informed consent
排除标准
- •Patients are NOT considered eligible for this study if any of the following conditions apply:
- •Patients with metastatic disease
- •Patients that are not candidates for surgery
- •Patients that refuse neoadjuvant treatment
结局指标
主要结局
patient preferences for operative vs. non-operative management of rectal cancer
时间窗: 8 months
Number of eligible patients who select operative versus non-operative management after successfully completing approximately 20 weeks of neoadjuvant treatment and the 10-12 week post treatment observation period
次要结局
- Patient adherence to surveillance protocols(5 years)
研究者
Eric Bravin
attending physician - medical oncology
Bassett Healthcare