Latitude - Lateral Lymph Node Attitude Study

Not Applicable

Not yet recruiting

• Conditions: Rectal Neoplasm Malignant

• Registration Number: NCT06896578
• Lead Sponsor: Sahlgrenska University Hospital

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.

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 Timeline

• Study First Submitted: 2025-01-09
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-15
• Primary Completion: 2029-02-01
• Study Completion: 2034-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local recurrence	Three years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden