Lateral Nodal Recurrence in Rectal Cancer

NCT04486131 | Recruiting

• 1 other identifier: A2021.0524.0001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Lateral local recurrence

  Lateral local recurrence diagnosed during the follow up

  3 years

Secondary Outcomes (6)

• Disease-free survival

  3 years

• Overall patient survival

  3 years

• Morbidity and functional outcomes assessed by LARS questions

  3 years

• Quality of life as assessed by the EORTC QLQ-CR29

  3 years

• Quality of life as assessed by the EQ-5D

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam University Medical Centers

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (3)

• Ogura A, Konishi T, Cunningham C, Garcia-Aguilar J, Iversen H, Toda S, Lee IK, Lee HX, Uehara K, Lee P, Putter H, van de Velde CJH, Beets GL, Rutten HJT, Kusters M; Lateral Node Study Consortium. Neoadjuvant (Chemo)radiotherapy With Total Mesorectal Excision Only Is Not Sufficient to Prevent Lateral Local Recurrence in Enlarged Nodes: Results of the Multicenter Lateral Node Study of Patients With Low cT3/4 Rectal Cancer. J Clin Oncol. 2019 Jan 1;37(1):33-43. doi: 10.1200/JCO.18.00032. Epub 2018 Nov 7.

  PMID: 30403572 RESULT

• Ogura A, Konishi T, Beets GL, Cunningham C, Garcia-Aguilar J, Iversen H, Toda S, Lee IK, Lee HX, Uehara K, Lee P, Putter H, van de Velde CJH, Rutten HJT, Tuynman JB, Kusters M; Lateral Node Study Consortium. Lateral Nodal Features on Restaging Magnetic Resonance Imaging Associated With Lateral Local Recurrence in Low Rectal Cancer After Neoadjuvant Chemoradiotherapy or Radiotherapy. JAMA Surg. 2019 Sep 1;154(9):e192172. doi: 10.1001/jamasurg.2019.2172. Epub 2019 Sep 18.

  PMID: 31268504 RESULT

• van Geffen EGM, Sluckin TC, Hazen SJA, Horsthuis K, Intven M, van Dieren S, Beets G, Lange MM, Taggart MW, Beets-Tan RGH, Marijnen CAM, Konishi T, Tanis PJ, Kusters M; LaNoReC study group. Optimised treatment of patients with enlarged lateral lymph nodes in rectal cancer: protocol of an international, multicentre, prospective registration study after extensive multidisciplinary training (LaNoReC). BMJ Open. 2024 Oct 16;14(10):e083225. doi: 10.1136/bmjopen-2023-083225.

  PMID: 39414276 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Miranda Kusters, MD, PhD

  VUMedicalCentre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda Kusters, MD, PhD

CONTACT

0031204444444; m.kusters@amsterdamumc.nl

Eline van Geffen, MD

CONTACT

0031204444444; lanorec@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 24, 2020
• Study Start: October 6, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting after initial publication of data
• Access Criteria: Requests will be assessed by the study team

Locations

NL (1)