Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pathologic complete response
研究概览
简要总结
This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).
详细描述
Introduction:
Rectal cancer is a highly prevalent disease all over the world. In Brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants.
Goals:
The aim of this study is to evaluate the pathologic complete response (pCR) of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant radiochemotherapy (RCT) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy.
Procedures:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+
排除标准
- •Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor
结局指标
主要结局
Pathologic complete response
时间窗: Through study completion, an average of 2 years
Pathologic evaluation of the surgical specimen
次要结局
- Disease free survival(2 years)
- Overall survival(2 years)
研究者
Marcos Santos
MD PhD
University of Brasilia