Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 19
- 主要终点
- Overall survival
研究概览
简要总结
For patients with primarily generalized colorectal cancer two treatment strategies are compared to establish which strategy gives best overall survival.
The traditional strategy is to first resect the primary colorectal tumour and then treat the metastases with chemotherapy followed if possible by surgery.
The alternative strategy is to first treat the metastases with chemotherapy followed if possible by surgery and only resect the primary colorectal tumour if there is hope for cure or if symptoms develop that necessitates treatment.
详细描述
Patients are randomized between the two treatment strategies mentioned above. After initial treatment the patients are categorized as palliative or treated with curative intent. Patients are followed with quality of life evaluations every 6 months. Outpatient visits, hospital care, examinations and treatment are recorded as well as complications and side effects. Survival is recorded and for those patients treated with curative intent the tumour situation 3 years after randomization is evaluated.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primarily generalized colorectal cancer diagnosed by pathology or typical appearance on x-ray or at endoscopy and where there is uncertainty regarding best treatment strategy
排除标准
- •Patients not willing to participate or unable to sign informed consent.
- •Patients with other malignancy with metastatic potential
- •Patients where synchronous resection of primary tumour and metastases is planned
- •Patients not fit for chemotherapy or surgery
- •Patients with locally unresectable primary tumours
- •Patients with symptoms from primary colorectal tumour necessitating resection
结局指标
主要结局
Overall survival
时间窗: 3 years after completion of study
次要结局
- 3 year survival for patients treated with curative intent(3 years after randomization)
- Palliative patients not receiving chemotherapy treated with the traditional strategy(Completion of study)
- Quality of life(Every 6 months up to 3 years)
- Health care consumption(Completion of study)
- Complications and side effects(Completion of study)
研究者
Gunnar Arbman
Consultant surgeon
Vrinnevi Hospital