Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

Chemoradiotherapy Clinical Trial

Official title:

Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05129774
• Other study ID #: V123456
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: October 2021
• Source: Qilu Hospital of Shandong University
• Contact: Yong Dai, M.D. Ph.D.
• Phone: +8618560085117
• Email: yongdai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiotherapy
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Lymph Node Excision
• Neoplasms

Intervention

Procedure:
• Radical 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
• Radical surgery without PALND
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year OS	5-year overall survival	From date of recruitment until the date of death from any cause, assessed up to 5 years
Secondary	DFS	5-year disease-free survival	From date of recruitment until the date of disease recurrece, assessed up to 5 years
Secondary	LFFS	Local failure free survival	From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Secondary	Postoperative complications	Postoperative complications	From date of surgery until the date of 30 days after surgery