search
Back to results

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy (PERN)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional resection
Proximally extended resection
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Resection

Proximally Extended Resection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of anastomotic leakage
Incidence of anastomotic stenosis
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
3-year disease free survival
5-year overall survival
Incidence of anastomotic haemorrhage
Incidence of intraoperative complication
Postoperative morbidity
Postoperative mortality
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.

Full Information

First Posted
January 5, 2016
Last Updated
April 23, 2020
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Shanghai Changzheng Hospital, Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02649647
Brief Title
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
Acronym
PERN
Official Title
Multicenter 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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Shanghai Changzheng Hospital, Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Resection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Proximally Extended Resection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional resection
Intervention Description
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
Intervention Name(s)
Proximally extended resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of major bowel dysfunction
Description
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.
Time Frame
at the time of 12 months after the restoration of defunctioning stoma
Secondary Outcome Measure Information:
Title
Incidence of anastomotic leakage
Time Frame
up to 6 months postoperatively
Title
Incidence of anastomotic stenosis
Time Frame
12 months postoperatively
Title
Incidence of major bowel dysfunction
Description
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Time Frame
at the time of 36 months after the restoration of defunctioning stoma
Title
Incidence of major bowel dysfunction
Description
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Time Frame
at the time of 60 months after the restoration of defunctioning stoma
Title
3-year disease free survival
Time Frame
3 years
Title
5-year overall survival
Time Frame
5 years
Title
Incidence of anastomotic haemorrhage
Time Frame
up to 1 month postoperatively
Title
Incidence of intraoperative complication
Time Frame
at the time of surgery
Title
Postoperative morbidity
Time Frame
up to 30 days postoperatively
Title
Postoperative mortality
Time Frame
up to 30 days postoperatively
Title
Quality of life impairment
Description
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time Frame
at the time of 12 months after the restoration of defunctioning stoma
Title
Quality of life impairment
Description
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time Frame
at the time of 36 months after the restoration of defunctioning stoma
Title
Quality of life impairment
Description
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time Frame
at the time of 60 months after the restoration of defunctioning stoma
Other Pre-specified Outcome Measures:
Title
Incidence of major bowel dysfunction in patients with tumor of different location
Time Frame
at the time of 12 months after the restoration of defunctioning stoma
Title
Incidence of major bowel dysfunction in patients with tumor of different location
Time Frame
at the time of 36 months after the restoration of defunctioning stoma
Title
Incidence of major bowel dysfunction in patients with tumor of different location
Time Frame
at the time of 60 months after the restoration of defunctioning stoma
Title
Incidence of anastomotic complication in patients with tumor of different location
Time Frame
up to 12 months postoperatively
Title
Operative duration by minutes
Time Frame
at the time of surgery
Title
Intraoperative blood loss by millilitres
Time Frame
at the time of surgery
Title
Postoperative rehabilitation time
Time Frame
up to 1 months postoperatively
Title
Postoperative hospital stay by days
Time Frame
up to 1 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiyuan Qin, M.D.
Phone
86-20-38254052
Email
qinqy3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Wang, MD, PhD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hui Wang, M.D.
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiyuan Qin, M.D.
Phone
86-20-38254052
Email
qinqy3@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

We'll reach out to this number within 24 hrs