Transanal local excision after radiotherapy vs total mesorectal excision for ultra-low T2N0M0 distal rectal cancer

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 randomized comparison examines two surgical strategies for ultra-low T2N0M0 rectal cancer. One arm uses transanal local excision following radiotherapy, while the other uses total mesorectal excision. The goal is to compare short- and long-term outcomes, including function and complications, to determine if a less invasive approach can provide similar cancer control. Eligible patients are adults with a small, non-fixed tumor within 4 cm of the anal verge and no distant metastasis. Multicenter collaboration is currently listed with a single lead institution in Nanjing, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years.
* Histologically confirmed adenocarcinoma by preoperative biopsy.
* Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.
* Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.
* Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.
* No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI.
* Ability to provide written informed consent.

Exclusion Criteria:

* History of other malignant tumors within the past 5 years.
* Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.
* Multiple primary colorectal tumors.
* Pregnant or breastfeeding women.
* Patients with plans for pregnancy.
* Severe psychiatric disorders.
* Previous treatment for rectal cancer, including radiotherapy or chemotherapy.
* Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease.
* Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment.
* Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum.
* Current participation in another clinical trial.

Where it's running

• Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yueming Sun, PhD
• Email: jssym@vip.sina.com
• Phone: 02568306026

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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.