Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT02649647

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2023-12-06

240

Participants Needed

1

Research Sites

669 weeks

Total Duration

On this page

Sponsors

S

Sixth Affiliated Hospital, Sun Yat-sen University

Lead Sponsor

S

Shanghai Changzheng Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • ECOG performance status of 0 to 2
  • Histologically confirmed adenocarcinoma of the rectum
  • Tumor located 12 cm or less from the anal verge
  • Cancer stage T3-4 or any node-positive disease
  • Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy
  • Receiving conventional fractionated radiotherapy of at least 45 Gy
  • Disease is resectable after neoadjuvant chemoradiotherapy
  • No distant metastasis
  • Suitable for sphincter-preserving surgery
  • Able to tolerate general anesthesia
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Prior or concurrent malignancies within the past 5 years, except treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
  • Presence of synchronous colon cancer
  • History of colorectal resection except appendectomy
  • Acute intestinal obstruction or perforation
  • Multiple visceral resections
  • History of abdominoperineal resection
  • American Society of Anesthesiologists (ASA) class III or IV
  • Pregnant or nursing, and fertile patients not using effective contraception
  • Serious cardiovascular disease, uncontrolled infections, or other uncontrolled serious diseases
  • Psychological, family, social, or geographical conditions that may affect study compliance or follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

Loading map...

Research Team

Q

Qiyuan Qin, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here