Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

NCT ID: NCT02649647

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2028-12-31

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Neoadjuvant therapy; Chemoradiotherapy; Resection margin; Bowel function; Anastomosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Resection

Patients receive conventional resection with standard proximal excision margin. The sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Group Type: ACTIVE_COMPARATOR

Conventional resection

Intervention Type: PROCEDURE

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

Patients receive proximally extended resection. The whole sigmoid colon and rectum proximal to the tumor is removed, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Group Type: EXPERIMENTAL

Proximally extended resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Wang, MD, PhD

Role: STUDY_DIRECTOR

Sixth Affiliated Hospital, Sun Yat-sen University

Hui Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiyuan Qin, M.D.

Role: CONTACT

Phone: 86-20-38254052

Email: qinqy3@mail.sysu.edu.cn

Facility Contacts

Qiyuan Qin, M.D.

Role: primary

Other Identifiers

PERN2015019

Identifier Type: -

Identifier Source: org_study_id