Rectal Neoplasm MalignantLatitudeNCT06896578
Latitude - Lateral Lymph Node Attitude Study
A study testing Lateral lymph node dissection in people with Rectal Neoplasm Malignant, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasm Malignant
- What is being tested?
- Lateral lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2025to 1 Feb 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Neoplasm Malignant
- Being tested
- Lateral lymph node dissection
- Keywords
- lateral lymph nodes, Quality of life, local recurrence, thrombosis, lymph oedema, lateral lymph node dissection
- Medical subject headings
- Rectal Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral lymph node dissectionProcedure or surgery
Also called Lateral lymph node clearance, Lateral lymph node removal
Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer surgery without lateral lymph node dissection | No intervention | 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 | 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 Receives: Procedure: Lateral lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three years
Secondary outcomes (44)
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
Measured: 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
Measured: 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
Measured: 5 years
Surgical morbidity (including reoperations) (Clavien Dindo score I-V)
Clavien-Dindo IIIb and more measured as proportion
Measured: 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.
Measured: 90 days
Perioperative blood loss
Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist)
Measured: 0-24 hours
Total operating time
Registration in operative CRF (op start and op end)
Measured: 0-24 hours
Length of hospital stay
Total days in hospital including referral to other hospital
Measured: 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
Measured: 365 days = 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Measured: 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Measured: 2 years
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Measured: 1 month
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Measured: 1 year
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Measured: 2 years
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Measured: 3 years
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Measured: 1 year
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Measured: 2 years
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Measured: 3 years
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Measured: 1 year
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Measured: 2 years
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Measured: 3 years
Health economic analysis
A total health economic analysis including societal costs
Measured: 1 year
Mortality
Dead by any cause
Measured: 1 year
Mortality
Dead by any cause
Measured: 2 years
Mortality
Dead by any cause
Measured: 3 years
5- year overall survival
Survival at 5 years
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
MRI interobserver variability
Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment
Measured: First month
MRI interobserver variability
Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment
Measured: First 6 months
MRI vs pathology
Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report
Measured: First 6 months
ctDNA at diagnosis
Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within the first 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, MD PhD, Principal investigator, Sahlgrenska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896578
- Sponsor's protocol ID
- Latitude
- Acronym
- Latitude
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Lymph Nodes in Rectal Cancer Attitude Study
- ClinicalTrials.gov ID
- NCT06896578
- Acronym / sponsor ID
- Latitude / Latitude
- Conditions
- Rectal Neoplasm Malignant
- Keywords
- lateral lymph nodes, Quality of life, local recurrence, thrombosis, lymph oedema, lateral lymph node dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer surgery without lateral lymph node dissection | No intervention | –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 | Procedure: Lateral lymph node dissectionRectal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral lymph node dissectionAlso: Lateral lymph node clearance, Lateral lymph node removalRemoval of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue | Procedure or surgery | Rectal cancer surgery with lateral lymph node dissection |
Primary outcome
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
44 secondary outcomes
Complications according to a composite outcome
Time frame: 90 days
Lateral local recurrence
Time frame: 3 years
Lateral local recurrence
Time frame: 5 years
Surgical morbidity (including reoperations) (Clavien Dindo score I-V)
Time frame: 90 days
Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)
Time frame: 90 days
Perioperative blood loss
Time frame: 0-24 hours
Total operating time
Time frame: 0-24 hours
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 length of hospital stay
Time frame: 365 days = 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Time frame: 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Time frame: 2 years
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Time frame: 3 years
Health related Quality of life
Time frame: 1 month postop
Health related Quality of life
Time frame: 1 year
Health related Quality of life
Time frame: 2 years
Health related Quality of life
Time frame: 3 years
Urinary function
Time frame: 1 month
Urinary function
Time frame: 1 year
Urinary function
Time frame: 2 years
Urinary function
Time frame: 3 years
Sexual function
Time frame: 1 year
Sexual function
Time frame: 2 years
Sexual function
Time frame: 3 years
Bowel and stoma function
Time frame: 1 year
Bowel and stoma function
Time frame: 2 years
Bowel and stoma function
Time frame: 3 years
Health economic analysis
Time frame: 1 year
Mortality
Time frame: 1 year
Mortality
Time frame: 2 years
Mortality
Time frame: 3 years
5- year overall survival
Time frame: 5 years
Pain according to brief pain inventory
Time frame: 1 month
Pain according to brief pain inventory
Time frame: 1 year
Pain according to brief pain inventory
Time frame: 2 years
Pain according to brief pain inventory
Time frame: 3 years
MRI interobserver variability
Time frame: First month
MRI interobserver variability
Time frame: First 6 months
MRI vs pathology
Time frame: First 6 months
ctDNA at diagnosis
Time frame: Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence
Value of immunoscore to predict response, and presence of lateral lymph nodes
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Rectal Neoplasm Malignant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Not yet recruitingPhase 2
PET/MRI in Rectal Cancer
Rectal Cancer
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Angenete, MD PhD principal investigator
Sahlgrenska Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral lymph node dissection in people with Rectal Neoplasm Malignant, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Angenete, MD PhD (+46760514441, eva.angenete@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.