Latitude - Lateral Lymph Node Attitude Study (Latitude)

Lateral Lymph Nodes in Rectal Cancer Attitude Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neoplasm Malignant
• Intervention / Treatment: Procedure: Lateral lymph node dissection

Detailed Description

Patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. The focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, QoL and oncologic outcome.

We will also aim to identify features on MRI to improve diagnostic ability.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Angenete, MD PhD; Phone Number: +46760514441; Email: eva.angenete@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, SE 416 85
    • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Rectal cancer surgery without lateral lymph node dissection; 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
Experimental: Rectal cancer surgery with lateral lymph node dissection; 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; Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue; Other Names: Lateral lymph node clearance; Lateral lymph node removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications according to a composite outcome	Composite outcome including: Comprehensive Complications index; Lymphedema (answer yes to questionnaire regarding swelling in right/left groin or leg); Thrombosis (registration in CRF) and questionnaire	90 days
Lateral local recurrence	A tumour recurrence located in the lateral compartments 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	3 years
Lateral local recurrence	A tumour recurrence located in the lateral compartments 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	5 years
Surgical morbidity (including reoperations) (Clavien Dindo score I-V)	Clavien-Dindo IIIb and more measured as proportion	90 days
Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)	All complications registered according to Clavien-Dindo using a calculator to identify a combination of the number and the severity of complications.	90 days
Perioperative blood loss	Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist)	0-24 hours
Total operating time	Registration in operative CRF (op start and op end)	0-24 hours
Length of hospital stay	Total days in hospital including referral to other hospital	during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu
Total length of hospital stay	Total number of days including readmissions	365 days = 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)	Clinical or radiological or patient reported thromobsis	1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)	Clinical or radiological or patient reported thromobsis	2 years
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)	Clinical or radiological or patient reported thromobsis	3 years
Health related Quality of life	Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.	1 month postop
Health related Quality of life	Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.	1 year
Health related Quality of life	Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.	2 years
Health related Quality of life	Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.	3 years
Urinary function	Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.	1 month
Urinary function	Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.	1 year
Urinary function	Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.	2 years
Urinary function	Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.	3 years
Sexual function	Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.	1 year
Sexual function	Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.	2 years
Sexual function	Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.	3 years
Bowel and stoma function	Measured in QoL questionnaire, major LARS (21-42 points)	1 year
Bowel and stoma function	Measured in QoL questionnaire, major LARS (21-42 points)	2 years
Bowel and stoma function	Measured in QoL questionnaire, major LARS (21-42 points)	3 years
Health economic analysis	A total health economic analysis including societal costs	1 year
Mortality	Dead by any cause	1 year
Mortality	Dead by any cause	2 years
Mortality	Dead by any cause	3 years
5- year overall survival	Survival at 5 years	5 years
Pain according to brief pain inventory	Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics	1 month
Pain according to brief pain inventory	Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics	1 year
Pain according to brief pain inventory	Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics	2 years
Pain according to brief pain inventory	Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics	3 years
MRI interobserver variability	Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment	First month
MRI interobserver variability	Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment	First 6 months
MRI vs pathology	Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report	First 6 months
ctDNA at diagnosis	Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes	Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence
Value of immunoscore to predict response, and presence of lateral lymph nodes	Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on MRI	1 month
Value of immunoscore to predict response, and presence of lateral lymph nodes	Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on pathology	Perioperative biopsies (within 6 weeks from inclusion)
Evaluation dose/fraction in relation to response to treatment	Details from CRF during treatment planning as well as prospectively collected treatment plans	Within the first 6 months.
Evaluation of number of fractions n relation to response to treatment	Details from CRF during treatment planning as well as prospectively collected treatment plans	Within the first 6 months
Evaluation of final dose to tumor and elective LN volume	Details from CRF during treatment planning as well as prospectively collected treatment plans	Within the first 6 months

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Eva Angenete, MD PhD, Sahlgrenska Universitetssjukhuset

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2034

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; thrombosis; local recurrence; lateral lymph node dissection; lateral lymph nodes; lymph oedema
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Latitude

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No