Latitude - Lateral Lymph Node Attitude Study

Sahlgrenska University Hospital

Status: Not yet enrolling

Conditions: Rectal Neoplasm Malignant

Treatments: Procedure: Lateral lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06896578

Latitude

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Rectal cancer surgery without lateral lymph node dissection

No Intervention group

Description:

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 group

Description:

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

Treatment:

Procedure: Lateral lymph node dissection