Comparing two surgical approaches for low rectal cancer treatment
Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis
This study is testing whether a combination of two surgical methods for low rectal cancer works better than just one after patients have received chemotherapy and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03587480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed adenocarcinoma of the rectum at clinical stage III, capable of undergoing radical resection.
Not a fit: Patients with a history of other cancers, inflammatory bowel disease, or those with advanced local tumor invasion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with low rectal cancer.
How similar studies have performed: While there are differing guidelines, this trial is designed to provide direct comparative evidence, making it a novel approach in the context of existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.