Rectal Neoplasm Malignant
Conditions
Keywords
Low rectal cancer, Total Mesorectal Excision (TME), neoadjuvant Chemo-radiotherapy (nCRT), lateral lymph node dissection (LLND)
Brief summary
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
Detailed description
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
Interventions
PROCEDURETME+LLND
patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
PROCEDURETME+nCRT
patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival | 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 | 36 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Operation day | in the perioperative period |
| Incidence of sexual dysfunction | 3 years | From the date of operation until the date of complication,assessed up to 3 years |
| Incidence of urinary dysfunction | 3 years | From the date of operation until the date of complication,assessed up to 3 years |
| Incidence of defecation dysfunction | 3 years | From the date of operation until the date of complication,assessed up to 3 years |
| Operative time | Operation day | Operation day |
| overall survival | From the date of operation until the date of death,assessed up to 5 years | 60 months after surgery |
| 3-year local recurrence rate | From date of operation until the date of local-recurrence (up to 3 years) | 36 months after surgery |
| 5-year disease-free survival | 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 | 60 months after surgery |
| the score of quality of life | 3 months after operation | The study investigate the quality of life using the WHOQOL Scale |
| incidence of Postoperative complications | 3 months | From the date of operation until the date of complication,assessed up to 3 months |
Countries
China
Contacts
Primary ContactYanxin Luo
Backup ContactShaoyong Peng
Outcome results
None listed