Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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
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