Actively Recruiting
Lateral Nodal Recurrence in Rectal Cancer
Led by Amsterdam UMC, location VUmc · Updated on 2023-01-19
200
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
Lateral Nodal Recurrence in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with rectal cancer having one or more lateral lymph nodes with a short-axis size of 7mm or more
- Patients with lateral lymph nodes 5mm or larger with one or more malignant features such as round shape, irregular margins, heterogeneity, or loss of fatty hilum
You will not qualify if you...
- Younger than 18 years old
- History of pelvic irradiation
- Previous lateral lymph node dissection related to pelvic cancer
- Presence of synchronous distant metastases
- Diagnosis of familial adenomatous polyposis
- Presence of synchronous colon cancer with a higher stage than rectal cancer
- Absolute contraindication for general anesthesia
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam University Medical Centers
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
Research Team
M
Miranda Kusters, MD, PhD
CONTACT
E
Eline van Geffen, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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