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

Sixth Affiliated Hospital, Sun Yat-sen University250 enrolled

Overview

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

There are significant differences between Japanese guidelines (JSCCR) and Western guidelines (NCCN, ESMO) in the treatment of low rectal cancer, especially in patients with regional lymph node metastasis. Japanese scholars advocated total meso rectal resection (TME) + Lateral lymph node dissection (LLND), However, European and American scholars advocate that only TME is used after new adjuvant chemo-radiation (nCRT), without LLND. Therefore, the purpose of this clinical trial was to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. This will provide a high level of clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Rectal Neoplasm Malignant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

3-year disease-free survival

36 months after surgery

Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes

Operative time

Operation day

Time frame: Operation day

Blood loss

in the perioperative period

Time frame: Operation day

Incidence of sexual dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Time frame: 3 years

Incidence of urinary dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Time frame: 3 years

Incidence of defecation dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Time frame: 3 years

incidence of Postoperative complications

From the date of operation until the date of complication,assessed up to 3 months

Time frame: 3 months

overall survival

60 months after surgery

Time frame: From the date of operation until the date of death,assessed up to 5 years

3-year local recurrence rate

36 months after surgery

Time frame: From date of operation until the date of local-recurrence (up to 3 years)

5-year disease-free survival

60 months after surgery

Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

the score of quality of life

The study investigate the quality of life using the WHOQOL Scale

Time frame: 3 months after operation

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts