Effect of Timing of Surgery After Neoadjuvant Chemoradiation on Histopathological Results, Complications, Recurrence and Survivals for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 主要终点
- Pathological Complete Response Rate
研究概览
简要总结
This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
- •Patients with histologically confirmed adenocarcinoma of the rectum
- •Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
- •Standardized total mesorectal excision surgery
- •Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
- •Elective operation
- •The patient must consent to be in the study and the informed consent must be signed
排除标准
- •Clinic stage I and IV cancer disease
- •Patients with malignant disease of the rectum other than adenocarcinoma
- •Recurrent rectal cancer
- •Emergency cases (Mechanical bowel obstruction, perforation)
- •Other previous or concurrent malignancies
- •Any contraindication for radiochemotherapy
- •Previous chemotherapy or radiotherapy to the pelvis
- •Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
- •American Society of Anesthesiologists Score >3 patients
研究组 & 干预措施
Early surgery group
İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.
干预措施: Total mesorectal excision before 56 days (4-8 weeks) (Procedure)
Late surgery group
İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.
干预措施: Total mesorectal excision after 56 days (8-12 weeks) (Procedure)
结局指标
主要结局
Pathological Complete Response Rate
时间窗: 2 months
Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated.
次要结局
- Overall Survival(5 years after surgery)
- Disease-free Survival(5 years after surgery)
- Tumour Regression Grade(30 days after surgery)
- Surgical Complications(90 days after surgery)
- Completeness of the Mesorectal Dissection(30 days after surgery)
- Recurrence(5 years after surgery)
研究者
Zekeriya Erhan Akgün
Professor of surgery
Ege University