Clinical trial NCT02649647: Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
Official title: Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Neoadjuvant therapy
Chemoradiotherapy
Resection margin
Bowel function
Anastomosis
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
name: Peking Union Medical College Hospital
First posted: 2016-01-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of major bowel dysfunction
timeFrame: at the time of 12 months after the restoration of defunctioning stoma
Secondary outcomes:
measure: Incidence of anastomotic leakage
timeFrame: up to 6 months postoperatively
measure: Incidence of anastomotic stenosis
timeFrame: 12 months postoperatively
measure: Incidence of major bowel dysfunction
timeFrame: at the time of 36 months after the restoration of defunctioning stoma
measure: Incidence of major bowel dysfunction
timeFrame: at the time of 60 months after the restoration of defunctioning stoma
measure: 3-year disease free survival
timeFrame: 3 years
measure: 5-year overall survival
timeFrame: 5 years
measure: Incidence of anastomotic haemorrhage
timeFrame: up to 1 month postoperatively
measure: Incidence of intraoperative complication
timeFrame: at the time of surgery
measure: Postoperative morbidity
timeFrame: up to 30 days postoperatively
measure: Postoperative mortality
timeFrame: up to 30 days postoperatively
measure: Quality of life impairment
timeFrame: at the time of 12 months after the restoration of defunctioning stoma
measure: Quality of life impairment
timeFrame: at the time of 36 months after the restoration of defunctioning stoma
measure: Quality of life impairment
timeFrame: at the time of 60 months after the restoration of defunctioning stoma
Other outcomes:
measure: Incidence of major bowel dysfunction in patients with tumor of different location
timeFrame: at the time of 12 months after the restoration of defunctioning stoma
measure: Incidence of major bowel dysfunction in patients with tumor of different location
timeFrame: at the time of 36 months after the restoration of defunctioning stoma
measure: Incidence of major bowel dysfunction in patients with tumor of different location
timeFrame: at the time of 60 months after the restoration of defunctioning stoma
measure: Incidence of anastomotic complication in patients with tumor of different location
timeFrame: up to 12 months postoperatively
measure: Operative duration by minutes
timeFrame: at the time of surgery
measure: Intraoperative blood loss by millilitres
timeFrame: at the time of surgery
measure: Postoperative rehabilitation time
timeFrame: up to 1 months postoperatively
measure: Postoperative hospital stay by days
timeFrame: up to 1 months postoperatively
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Lei Wang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Hui Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: