Lateral Nodal Recurrence in Rectal Cancer
Recruiting · NCT04486131 · Observational (researchers observe without assigning treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →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%.
Who can take part
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
Where it is running
1 location listed.
- Amsterdam University Medical Centers - Amsterdam, North Holland, Netherlands