Clinical trial NCT06896578: Latitude - Lateral Lymph Node Attitude Study
Official title: Lateral Lymph Nodes in Rectal Cancer Attitude Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neoplasm Malignant
Keywords: lateral lymph nodes
Quality of life
local recurrence
thrombosis
lymph oedema
lateral lymph node dissection
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2025-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local recurrence
timeFrame: Three years
Secondary outcomes:
measure: Complications according to a composite outcome
timeFrame: 90 days
measure: Lateral local recurrence
timeFrame: 3 years
measure: Lateral local recurrence
timeFrame: 5 years
measure: Surgical morbidity (including reoperations) (Clavien Dindo score I-V)
timeFrame: 90 days
measure: Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)
timeFrame: 90 days
measure: Perioperative blood loss
timeFrame: 0-24 hours
measure: Total operating time
timeFrame: 0-24 hours
measure: Length of hospital stay
timeFrame: during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu
measure: Total length of hospital stay
timeFrame: 365 days = 1 year
measure: Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
timeFrame: 1 year
measure: Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
timeFrame: 2 years
measure: Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
timeFrame: 3 years
measure: Health related Quality of life
timeFrame: 1 month postop
measure: Health related Quality of life
timeFrame: 1 year
measure: Health related Quality of life
timeFrame: 2 years
measure: Health related Quality of life
timeFrame: 3 years
measure: Urinary function
timeFrame: 1 month
measure: Urinary function
timeFrame: 1 year
measure: Urinary function
timeFrame: 2 years
measure: Urinary function
timeFrame: 3 years
measure: Sexual function
timeFrame: 1 year
measure: Sexual function
timeFrame: 2 years
measure: Sexual function
timeFrame: 3 years
measure: Bowel and stoma function
timeFrame: 1 year
measure: Bowel and stoma function
timeFrame: 2 years
measure: Bowel and stoma function
timeFrame: 3 years
measure: Health economic analysis
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Mortality
timeFrame: 2 years
measure: Mortality
timeFrame: 3 years
measure: 5- year overall survival
timeFrame: 5 years
measure: Pain according to brief pain inventory
timeFrame: 1 month
measure: Pain according to brief pain inventory
timeFrame: 1 year
measure: Pain according to brief pain inventory
timeFrame: 2 years
measure: Pain according to brief pain inventory
timeFrame: 3 years
measure: MRI interobserver variability
timeFrame: First month
measure: MRI interobserver variability
timeFrame: First 6 months
measure: MRI vs pathology
timeFrame: First 6 months
measure: ctDNA at diagnosis
timeFrame: Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence
measure: Value of immunoscore to predict response, and presence of lateral lymph nodes
timeFrame: 1 month
measure: Value of immunoscore to predict response, and presence of lateral lymph nodes
timeFrame: Perioperative biopsies (within 6 weeks from inclusion)
measure: Evaluation dose/fraction in relation to response to treatment
timeFrame: Within the first 6 months.
measure: Evaluation of number of fractions n relation to response to treatment
timeFrame: Within the first 6 months
measure: Evaluation of final dose to tumor and elective LN volume
timeFrame: Within the first 6 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset
name: Eva Angenete, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: