Latitude - Lateral Lymph Node Attitude Study

NCT06896578 | Not Yet Recruiting

• 1 other identifier: Latitude
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects. This study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.

Conditions

Rectal Neoplasm Malignant

Keywords

lateral lymph nodes; Quality of life; local recurrence; thrombosis; lymph oedema; lateral lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Local recurrence

  A tumour recurrence within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology

  Three years

Secondary Outcomes (44)

• Complications according to a composite outcome

  90 days

• Lateral local recurrence

  3 years

• Lateral local recurrence

  5 years

• Surgical morbidity (including reoperations) (Clavien Dindo score I-V)

  90 days

• Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)

  90 days

Study Arms (2)

Rectal cancer surgery without lateral lymph node dissection

NO INTERVENTION

Rectal cancer surgery without lateral lymph node dissection. Applicable if no lateral lymph nodes on primary MRI or lateral lymph nodes ≤4 mm after neoadjuvant treatment No lateral lymph node dissection

Rectal cancer surgery with lateral lymph node dissection

EXPERIMENTAL

Rectal cancer surgery with lateral lymph node dissection. Applicable if lateral lymph nodes on primary MRI that persist after neoadjuvant treatment (\> 4 mm) . Lateral lymph node dissection

Procedure: Lateral lymph node dissection

Interventions

Lateral lymph node dissection PROCEDURE

Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue

Also known as: Lateral lymph node clearance, Lateral lymph node removal

Rectal cancer surgery with lateral lymph node dissection

Eligibility Criteria

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

You may qualify if:

• years or older
• written informed consent
• adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and/or MRI
• clinical tumor (cT) stage cT3, cT4a or cT4b on MRI or
• adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and/or MRI regardless of T/N stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic MRI or PET-CT

You may not qualify if:

• Not biopsy confirmed rectal cancer (adenocarcinoma)
• Recurrent rectal cancer
• Age below 18
• Participation in other trials in conflict with the protocol and end-points of the Latitude study
• No informed consent

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms; Thrombosis

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; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eva Angenete, MD PhD

  Sahlgrenska Universitetssjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Angenete, MD PhD

CONTACT

+46760514441; eva.angenete@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be treated according to their findings on primary MRI. They will initiallly be divided into two groups: No neoadjuvant treatment or neoadjuvant treatment. If no neoadjuvant treatment the patients undergo rectal surgery. If neoadjuvant treatment and lateral lymph nodes remain after neoadjuvant treatment (size \>4 mm) then the patients will undergo lateral lymph node dissection. If neoadjuvant treatment and lateral lymph nodes are ≤4 mm after neoadjuvant treatment then the patients will undergo rectal surgery.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: March 26, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2034
• Last Updated: August 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)