Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Rectal Cancer Clinical Trial

— PERN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02649647
• Other study ID #: PERN2015019
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Qiyuan Qin, M.D.
• Phone: 86-20-38254052
• Email: qinqy3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ? or ?

• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Peking Union Medical College Hospital, Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of major bowel dysfunction in patients with tumor of different location		at the time of 12 months after the restoration of defunctioning stoma
Other	Incidence of major bowel dysfunction in patients with tumor of different location		at the time of 36 months after the restoration of defunctioning stoma
Other	Incidence of major bowel dysfunction in patients with tumor of different location		at the time of 60 months after the restoration of defunctioning stoma
Other	Incidence of anastomotic complication in patients with tumor of different location		up to 12 months postoperatively
Other	Operative duration by minutes		at the time of surgery
Other	Intraoperative blood loss by millilitres		at the time of surgery
Other	Postoperative rehabilitation time		up to 1 months postoperatively
Other	Postoperative hospital stay by days		up to 1 months postoperatively
Primary	Incidence of major bowel dysfunction	Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.	at the time of 12 months after the restoration of defunctioning stoma
Secondary	Incidence of anastomotic leakage		up to 6 months postoperatively
Secondary	Incidence of anastomotic stenosis		12 months postoperatively
Secondary	Incidence of major bowel dysfunction	Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.	at the time of 36 months after the restoration of defunctioning stoma
Secondary	Incidence of major bowel dysfunction	Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.	at the time of 60 months after the restoration of defunctioning stoma
Secondary	3-year disease free survival		3 years
Secondary	5-year overall survival		5 years
Secondary	Incidence of anastomotic haemorrhage		up to 1 month postoperatively
Secondary	Incidence of intraoperative complication		at the time of surgery
Secondary	Postoperative morbidity		up to 30 days postoperatively
Secondary	Postoperative mortality		up to 30 days postoperatively
Secondary	Quality of life impairment	Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.	at the time of 12 months after the restoration of defunctioning stoma
Secondary	Quality of life impairment	Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.	at the time of 36 months after the restoration of defunctioning stoma
Secondary	Quality of life impairment	Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.	at the time of 60 months after the restoration of defunctioning stoma