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Clinical Trials in the Netherlands / NCT04486131
Recruiting Observational

Lateral Nodal Recurrence in Rectal Cancer

NCT04486131 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Amsterdam UMC, location VUmc
Phase
Observational
Started
2020-10-06
Last updated
2023-01-19

Condition(s) studied

Rectal Cancer

Study summary

Local recurrence rates in rectal cancer have reduced dramatically since the introduction of the total mesorectal excision (TME) technique and neoadjuvant (chemo)radiotherapy (C))RT) to overall rates of 5-year local recurrence to 5-10%.

However, distal rectal cancers have a tendency to spread to lateral lymph nodes and it was recently shown that patients with enlarged lateral lymph nodes of ≥7mm short-axis size have a considerable chance of a local recurrence: 15-20%. This is regardless of CRT with TME in two retrospective cohorts (Lateral Node Consortium and Snapshot Rectal Cancer 2016 study). According to the Lateral Node Consortium study, this rate was significantly reduced to \<6% when performing a lateral lymph node dissection (LLND) after (C)RT + TME.

A major drawback of these recent multi-center studies is their retrospective nature. Therefore, in the Netherlands, radiologists, radiation oncologists, surgeons and pathologists have recently been educated and trained to enhance knowledge and awareness of LLNs and to implement nerve-sparing minimally invasive LLND.

The LaNoReC trial is a prospective registration study aimed at evaluating oncological outcomes after multi-disciplinary training. The main question of this study is whether, after dedicated training and the performance of LLNDs, the lateral local recurrence rate in rectal cancers with enlarged nodes (≥7mm) can be reduced to below 6%.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: • All patients with rectal cancer with one or more lateral nodes with a short-axis of ≥7mm or ≥5mm with one or more malignant features (i.e. round shape, irregular margins, heterogeneity, loss of fatty hilum). Exclusion Criteria: * Younger than 18 years old * Pelvic irradiation in the medical history * Previous lateral lymph node dissection related to pelvic malignancy * Synchronous distant metastases * Familiar adenomatous polyposis * Synchronous colon cancer with a higher stage than rectal cancer * Absolute contraindication for general anaesthesia * Pregnancy

Primary outcome measure(s)

  • Lateral local recurrence — 3 years
    Lateral local recurrence diagnosed during the follow up

Trial sites (1)

FacilityCityRegionStatus
Amsterdam University Medical Centers Amsterdam North Holland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04486131 on ClinicalTrials.gov ↗ ← All trials in the Netherlands