Surgery for rectal cancer after chemotherapy and radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of proximally extended resection compared to conventional resection in patients with rectal cancer who have undergone neoadjuvant chemoradiotherapy. The study aims to determine whether this surgical approach can improve postoperative bowel function and reduce complications such as anastomotic leakage. Eligible participants include adults aged 18-75 with specific tumor characteristics and no evidence of distant metastasis. The trial is conducted at the Sixth Affiliated Hospital of Sun Yat-sen University and involves collaboration with other prominent medical institutions.

Why it matters

Who can join: the full rules

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

Where it's running

• Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Hui Wang, M.D. — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Qiyuan Qin, M.D.
• Email: qinqy3@mail.sysu.edu.cn
• Phone: 86-20-38254052

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.