Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Официальное название

Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Обзор

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery. Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis. It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.

Вмешательства

• Процедура Conventional resection
  The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
• Процедура Proximally extended resection
  The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Первичные конечные точки

• Incidence of major bowel dysfunction [Срок оценки: at the time of 12 months after the restoration of defunctioning stoma]

Вторичные конечные точки (12)

• Incidence of anastomotic leakage [Срок оценки: up to 6 months postoperatively]
• Incidence of anastomotic stenosis [Срок оценки: 12 months postoperatively]
• Incidence of major bowel dysfunction [Срок оценки: at the time of 36 months after the restoration of defunctioning stoma]
• Incidence of major bowel dysfunction [Срок оценки: at the time of 60 months after the restoration of defunctioning stoma]
• 3-year disease free survival [Срок оценки: 3 years]
• 5-year overall survival [Срок оценки: 5 years]
• Incidence of anastomotic haemorrhage [Срок оценки: up to 1 month postoperatively]
• Incidence of intraoperative complication [Срок оценки: at the time of surgery]
• Postoperative morbidity [Срок оценки: up to 30 days postoperatively]
• Postoperative mortality [Срок оценки: up to 30 days postoperatively]
• Quality of life impairment [Срок оценки: at the time of 12 months after the restoration of defunctioning stoma]
• Quality of life impairment [Срок оценки: at the time of 36 months after the restoration of defunctioning stoma]

Критерии участия

Критерии включения

• Age: 18-75 years old
• ECOG performance status: 0-2
• Histologically confirmed adenocarcinoma of the rectum
• Distal border of the tumor located ≤ 12 cm from the anal verge
• Primary stage T3-4 or any node-positive disease
• Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy
• Conventional fractionated radiotherapy of at least 45 Gy
• Resectable disease after neoadjuvant chemoradiotherapy
• No evidence of distant metastasis
• Amenable to sphincter-preserving surgery
• Tolerable to general anesthesia
• Provision of written informed consent

Критерии исключения

• Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
• Synchronous colon cancer
• History of colorectal resection except appendectomy
• Acute intestinal obstruction or perforation
• Multiple visceral resection
• Abdominoperineal resection
• American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
• Pregnant or nursing, fertile patients do not use effective contraception
• Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT02649647 · PERN2015019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗