The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
研究概览
简要总结
According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.
详细描述
Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. After 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. Patients with good pathological response (complete response or downstaging to ypT1 disease)are followed up. Conversion to open surgery is offered to patients with poor pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. Rescue surgery is offered in patients with local recurrence.
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
- •Biopsy proven good or moderately differentiated adenocarcinoma of rectum
- •Extraperitoneal tumour (< 3-4 cm; unfavourable cT1 or cT2-3; N0)
- •No evidence of distant metastases on chest X-ray and abdominal CT or sonography
- •Signed by patient written informed consent
排除标准
- •Poorly differentiated pathology (G3)
- •Patients unfit for chemotherapy
- •No agreement for randomisation
结局指标
主要结局
The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
时间窗: Surrogate endpoint available immediatly after surgery.
次要结局
- The rate of local control, overall survival and disease-free survival and toxicity.(5 years)