Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy: a Phase III Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 394
- 试验地点
- 2
- 主要终点
- Local recurrence-free survival
研究概览
简要总结
COPPER is an international, multicenter, parallel-arm, phase III randomized controlled trial comparing two local treatment strategies (SABR or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases
详细描述
The study is formally endorsed by the Dutch Society of Lung Surgery (NVvL), the Dutch Society of Cardiothoracic Surgery (NVT), the Dutch Society of Radiation Oncology (NVRO). The main objective of the proposed randomized trial is to compare efficacy of SABR to the efficacy of metastasectomy with regards to the primary endpoint (local recurrence free survival at 5 years) in patients with limited colorectal pulmonary metastases. This will determine the most effective local treatment modality. The investigators hypothesize that patients with limited colorectal pulmonary metastases will have non-inferior overall survival after pulmonary metastasectomy compared to SABR, however metastasectomy will result in superior local recurrence free survival at five years when compared to SABR. In addition, the investigators hypothesize that SABR is associated with lower morbidity, comparable quality of life and comparable health care costs compared to metastasectomy. Recurrent metastases are preferably treated by the index treatment to which the patient was randomized, local recurrent metastases are preferably treated by means of cross-over between both arms. Comparing metastasectomy to SABR for patients with colorectal pulmonary metastases will present the international community the evidence needed to better select patients for local radical treatment, while diminishing uncertainty for patients and care givers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG)-Performance status 0 - 2
- •Willing to provide informed consent
- •Patients with 1 to 3 lung metastases from colorectal cancer eligible for both a minimally invasive surgical resection and SABR, as assessed by the multidisciplinary tumor board (MDT)
- •Radically treated primary colorectal cancer
- •Patient is able and willing to complete the quality-of-life questionnaires
- •Previous liver metastases are radically treated with curative intent
- •Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
排除标准
- •Previous or present metastases outside liver or lungs
- •Concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers)
- •Hilar or mediastinal lymph node metastases
- •Poor cardiopulmonary function test
- •Inability to treat all colorectal metastases
- •Surgical resection by means of a bilobectomy or pneumonectomy
结局指标
主要结局
Local recurrence-free survival
时间窗: From date of randomization through study completion, up to 10 years
Time from randomization to local recurrence or death from any cause
次要结局
- Quality of life (QoL) assessment - EuroQoL (EQ-5D-5L)(5 years)
- Quality of life assessment - Functional Assessment of Cancer Therapy: General (FACT-G)(5 years)
- Health economic evaluation - Institute for Medical Technology Assessment (iMTA) - iMTA Medical Cost Questionnaire (iMCQ)(5 years)
- Progression-free survival (PFS)(5 years)
- Health economic evaluation - iMTA Productivity Cost Questionnaire (iPCQ)(5 years)
- Tumor patterns of failure(5 years)
- Multiparameter flow cytometric analyses (FACS)(1 months)
- Overall survival (OS)(5 years)
- Local recurrence rate (LRR) per tumor(5 years)
- Rate of adverse events(2 years)
研究者
Martijn van Dorp
Principal Investigator
Amsterdam UMC, location VUmc