Comparing two surgical approaches for low rectal cancer treatment

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 aims to compare the efficacy and safety of two treatment strategies for low rectal cancer with regional lymph node metastasis: Total Mesorectal Excision (TME) combined with Lateral Lymph Node Dissection (LLND) versus TME alone following Neoadjuvant Chemo-radiotherapy (nCRT). The study addresses significant differences in treatment guidelines between Japanese and Western medical practices. By enrolling patients with histologically confirmed adenocarcinoma, the trial will provide high-level clinical evidence to inform treatment decisions for this condition. The outcomes will help clarify the best surgical approach for patients with suspected local lymph node metastasis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
2. Tumor is capable of performing radical recession
3. No past history of chemotherapy, pelvic radiation of other cancers.
4. Written informed consent
5. Lower tumor margin is confirmed below the peritoneal reflection
6. Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -

Exclusion Criteria:

1. Past history of other cancers
2. Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)
3. Combine with inflammatory bowl disease(IBD)
4. Recurrence tumor or invade other organs
5. Combine with obstruction,perforation or bleeding which need emergency surgery.
6. Local tumor invade the external sphincter, levator ani muscle or adjacent organs
7. Participant join other clinical trials in 4 weeks.
8. American Society of Anesthesiologists(ASA) ≥Ⅳ and/or Eastern Cooperative Oncology Group(ECOG) ≤2
9. Pregnant or lactating patients
10. Severity infection before operation
11. Psychological disorder
12. Severe dysfunction of organs or other contraindications
13. Cardiac infarction within six months
14. Severe pulmonary emphysema and pulmonary fibrosis
15. Doctor's decision for exclusion
16. Operative findings:

Tumor invade other organs Lower tumor margin is above the peritoneal reflection

Where it's running

• The Sixth Affiliate Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yanxin Luo — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Yanxin Luo
• Email: luoyx25@mail.sysu.edu.cn
• Phone: 020-38250745

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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.