Chemoradiotherapy, Colorectal Neoplasms Malignant, Lymph Node Excision
Conditions
Brief summary
In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis
Interventions
PROCEDURERadical surgery with PALND
sufficient resection margins of the tumor, D3 dissection of the regional lymph nodes and para-aortic lymph node dissection from the bifurcation of iliac artery to the left renal vein via laparoscopic approach
PROCEDURERadical surgery without PALND
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age at enrollment is ≥ 18 and ≤ 75 years * ECOG PS 0-1 * histologically confirmed left-sided colon and rectal carcinoma * synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery * patients potential to receive surgery and achieve no evidence of disease (NED) * able to tolerate surgery * providing written informed consent
Exclusion criteria
* local invasion or distant metastasis other than para-aoritc lymph nodes * history of other malignant tumor * coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection) * emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year OS | From date of recruitment until the date of death from any cause, assessed up to 5 years | 5-year overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | From date of recruitment until the date of disease recurrece, assessed up to 5 years | 5-year disease-free survival |
| LFFS | From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years | Local failure free survival |
| Postoperative complications | From date of surgery until the date of 30 days after surgery | Postoperative complications |
Countries
China
Contacts
Primary ContactYong Dai, M.D. Ph.D.
Backup ContactXiang Zhang, M.D. Ph.D.
Outcome results
None listed