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NCT Number: NCT06896578

Latitude - Lateral Lymph Node 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.

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Key information

Conditions

Rectal Neoplasm Malignant Cardiovascular Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Lateral lymph node clearance, Lateral lymph node removal

Primary outcomes

  1. Local recurrence

    Time frame: 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 outcomes

  1. Complications according to a composite outcome

    Time frame: 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

  2. Lateral local recurrence

    Time frame: 3 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

  3. Lateral local recurrence

    Time frame: 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

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

    Time frame: 90 days

    Clavien-Dindo IIIb and more measured as proportion

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

    Time frame: 90 days

    All complications registered according to Clavien-Dindo using a calculator to identify a combination of the number and the severity of complications.

  6. Perioperative blood loss

    Time frame: 0-24 hours

    Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist)

  7. Total operating time

    Time frame: 0-24 hours

    Registration in operative CRF (op start and op end)

  8. Length of hospital stay

    Time frame: 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

  9. Total length of hospital stay

    Time frame: 365 days = 1 year

    Total number of days including readmissions

  10. Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)

    Time frame: 1 year

    Clinical or radiological or patient reported thromobsis

  11. Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)

    Time frame: 2 years

    Clinical or radiological or patient reported thromobsis

  12. Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)

    Time frame: 3 years

    Clinical or radiological or patient reported thromobsis

  13. Health related Quality of life

    Time frame: 1 month postop

    Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.

  14. Health related Quality of life

    Time frame: 1 year

    Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.

  15. Health related Quality of life

    Time frame: 2 years

    Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.

  16. Health related Quality of life

    Time frame: 3 years

    Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.

  17. Urinary function

    Time frame: 1 month

    Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.

  18. Urinary function

    Time frame: 1 year

    Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.

  19. Urinary function

    Time frame: 2 years

    Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.

  20. Urinary function

    Time frame: 3 years

    Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.

  21. Sexual function

    Time frame: 1 year

    Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.

  22. Sexual function

    Time frame: 2 years

    Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.

  23. Sexual function

    Time frame: 3 years

    Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.

  24. Bowel and stoma function

    Time frame: 1 year

    Measured in QoL questionnaire, major LARS (21-42 points)

  25. Bowel and stoma function

    Time frame: 2 years

    Measured in QoL questionnaire, major LARS (21-42 points)

  26. Bowel and stoma function

    Time frame: 3 years

    Measured in QoL questionnaire, major LARS (21-42 points)

  27. Health economic analysis

    Time frame: 1 year

    A total health economic analysis including societal costs

  28. Mortality

    Time frame: 1 year

    Dead by any cause

  29. Mortality

    Time frame: 2 years

    Dead by any cause

  30. Mortality

    Time frame: 3 years

    Dead by any cause

  31. 5- year overall survival

    Time frame: 5 years

    Survival at 5 years

  32. Pain according to brief pain inventory

    Time frame: 1 month

    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

  33. Pain according to brief pain inventory

    Time frame: 1 year

    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

  34. Pain according to brief pain inventory

    Time frame: 2 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

  35. Pain according to brief pain inventory

    Time frame: 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

  36. MRI interobserver variability

    Time frame: First month

    Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment

  37. MRI interobserver variability

    Time frame: First 6 months

    Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment

  38. MRI vs pathology

    Time frame: First 6 months

    Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report

  39. ctDNA at diagnosis

    Time frame: Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence

    Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes

  40. Value of immunoscore to predict response, and presence of lateral lymph nodes

    Time frame: 1 month

    Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on MRI

  41. Value of immunoscore to predict response, and presence of lateral lymph nodes

    Time frame: 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

  42. Evaluation dose/fraction in relation to response to treatment

    Time frame: Within the first 6 months.

    Details from CRF during treatment planning as well as prospectively collected treatment plans

  43. Evaluation of number of fractions n relation to response to treatment

    Time frame: Within the first 6 months

    Details from CRF during treatment planning as well as prospectively collected treatment plans

  44. Evaluation of final dose to tumor and elective LN volume

    Time frame: Within the first 6 months

    Details from CRF during treatment planning as well as prospectively collected treatment plans

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Angenete, MD PhD

CONTACT

[email protected]

+46760514441

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Official study title

Lateral Lymph Nodes in Rectal Cancer Attitude Study

Acronym: Latitude

Important dates

Study start
2025
Primary completion
2029
Study completion
2034
First posted
Mar 26, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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