NCT02649647Recruiting
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Source: ClinicalTrials.gov · Last updated 6 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 5 Jan 2016
- Start date
- 1 Feb 2016
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT02649647
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Feb 2016 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Multiple visceral resection
- Abdominoperineal resection
- Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
Other illness
- Synchronous colon cancer
- History of colorectal resection except appendectomy
- Acute intestinal obstruction or perforation
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Other
- American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
- Pregnant or nursing, fertile patients do not use effective contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.