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Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

ConditionsColorectal Neoplasms MalignantLymph Node ExcisionChemoradiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorQilu Hospital of Shandong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Radical surgery with PALND

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: radical surgery with PALNDExperimental treatment 1 intervention
Group B: radical surgery without PALNDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

5-year OS

5-year overall survival

Time frame
From date of recruitment until the date of death from any cause, assessed up to 5 years

Secondary outcomes

1

DFS

5-year disease-free survival

Time frame
From date of recruitment until the date of disease recurrece, assessed up to 5 years
2

LFFS

Local failure free survival

Time frame
From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
3

Postoperative complications

Postoperative complications

Time frame
From date of surgery until the date of 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: