Lateral Lymph Nodes in Rectal Cancer Attitude Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Local recurrence
研究概览
简要总结
Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects.
This study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.
详细描述
Patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. The focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, QoL and oncologic outcome.
We will also aim to identify features on MRI to improve diagnostic ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18 years or older
- •written informed consent
- •adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and/or MRI
- •clinical tumor (cT) stage cT3, cT4a or cT4b on MRI or
- •adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and/or MRI regardless of T/N stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic MRI or PET-CT
排除标准
- •Not biopsy confirmed rectal cancer (adenocarcinoma)
- •Recurrent rectal cancer
- •Age below 18
- •Participation in other trials in conflict with the protocol and end-points of the Latitude study
- •No informed consent
结局指标
主要结局
Local recurrence
时间窗: Three years
A tumour recurrence within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology
次要结局
- Complications according to a composite outcome(90 days)
- Lateral local recurrence(5 years)
- Surgical morbidity (including reoperations) (Clavien Dindo score I-V)(90 days)
- Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)(90 days)
- Perioperative blood loss(0-24 hours)
- Total operating time(0-24 hours)
- Length of hospital stay(during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu)
- Total length of hospital stay(365 days = 1 year)
- Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)(3 years)
- Health related Quality of life(3 years)
- Urinary function(3 years)
- Sexual function(3 years)
- Bowel and stoma function(3 years)
- Health economic analysis(1 year)
- Mortality(3 years)
- 5- year overall survival(5 years)
- Pain according to brief pain inventory(3 years)
- MRI interobserver variability(First 6 months)
- MRI vs pathology(First 6 months)
- ctDNA at diagnosis(Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence)
- Value of immunoscore to predict response, and presence of lateral lymph nodes(Perioperative biopsies (within 6 weeks from inclusion))
- Evaluation dose/fraction in relation to response to treatment(Within the first 6 months.)
- Evaluation of number of fractions n relation to response to treatment(Within the first 6 months)
- Evaluation of final dose to tumor and elective LN volume(Within the first 6 months)
研究者
Eva Angenete
Professor
Sahlgrenska University Hospital