Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

NCT02649647 · tracked via the Priya Life Science China tracker

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Phase

Not applicable

Started

2016-02

Last updated

2023-12-06

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Conventional resectionProximally extended resection

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

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

Primary outcome measure(s)

Incidence of major bowel dysfunction — at the time of 12 months after the restoration of defunctioning stoma
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.

Trial sites (1)

Facility	City	Region	Status
Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

More Sixth Affiliated Hospital, Sun Yat-sen University trials in China

Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial Recruiting

Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer Recruiting

Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer Starting soon

Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer Recruiting

NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC Starting soon

Other trials for the same condition

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC Recruiting

Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer Starting soon

Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial Recruiting

Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer Starting soon

Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02649647 on ClinicalTrials.gov ↗ ← All trials in China