Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Disease-free survival
研究概览
简要总结
The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are
- if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere
- what is the organ preservation rate
- what is the local regrowth rate
详细描述
Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response.
Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences.
Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM.
Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM.
Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years.
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
- •Histopathological verification of primary rectal adenocarcinoma
- •Complete clinical response at response assessment after neoadjuvant therapy
- •Informed consent to organ preservation study
排除标准
- •Evidence of metastatic disease (fulfilling M-class criteria of TNM)
- •No neoadjuvant therapy
- •Inability to understand the information related to harms and benefits
结局指标
主要结局
Disease-free survival
时间窗: 2 years
Survival from complete clinical response to locoregional failure or distant metastases
次要结局
- Overall survival(5 years)
- Post local regrowth disease-free survival(5 years)
- TME-free survival(5 years)
- Distant metastases-free survival(5 years)
- ctDNA-free survival(5 years)
- Post local regrowth overall survival(5 years)
- Local regrowth-free survival(5 years)
- Local recurrence-free survival(5 years)
- Disease-free survival(5 years)
- Salvage rate after local regrowth(5 years)
- Quality of life score(5 years)
- Complication rates(5 years)