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Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

RecruitingNAAges 18 Years - 75 YearsAllSixth Affiliated Hospital, Sun Yat-sen University
NCT02649647 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 improv

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📋 Eligibility rules (as published)
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
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What it tests

  • Conventional resection
  • Proximally extended resection
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Where

1 site
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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