Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

NCT02649647 | Recruiting DMC

• 1 other identifier: PERN2015019
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of anastomotic leakage

  up to 6 months postoperatively

• Incidence of anastomotic stenosis

  12 months postoperatively

• Incidence of major bowel dysfunction

  at the time of 36 months after the restoration of defunctioning stoma

• Incidence of major bowel dysfunction

  at the time of 60 months after the restoration of defunctioning stoma

• 3-year disease free survival

  3 years

Other Outcomes (8)

• Incidence of major bowel dysfunction in patients with tumor of different location

  at the time of 12 months after the restoration of defunctioning stoma

• Incidence of major bowel dysfunction in patients with tumor of different location

  at the time of 36 months after the restoration of defunctioning stoma

• Incidence of major bowel dysfunction in patients with tumor of different location

  at the time of 60 months after the restoration of defunctioning stoma

Study Arms (2)

Conventional Resection

ACTIVE COMPARATOR

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.

Procedure: Conventional resection

Proximally Extended Resection

EXPERIMENTAL

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.

Procedure: Proximally extended resection

Interventions

Conventional resection 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.

Conventional Resection

Proximally extended resection 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.

Proximally Extended Resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Shanghai Changzheng Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Wang, MD, PhD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

• Hui Wang, M.D.

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiyuan Qin, M.D.

CONTACT

86-20-38254052; qinqy3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 7, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CN (1)