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โ† Trials
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Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy

RecruitingNAAges 18 Years - 75 YearsAllSixth Affiliated Hospital, Sun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage โ…ข 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) โ‰ฅโ…ฃ and/or Eastern Cooperative Oncology Group(ECOG) โ‰ค2 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
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What it tests

  • TME+LLND
  • TME+nCRT
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Where

1 site
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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