Health TrialsbyHealthPanel

Latitude - Lateral Lymph Node Attitude Study

ConditionRectal Neoplasm Malignant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lateral lymph node dissection

    Procedure/Surgery

    Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Rectal cancer surgery without lateral lymph node dissectionNo intervention 0 interventions
Group B: Rectal cancer surgery with lateral lymph node dissectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Three years

Secondary outcomes

1

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

Time frame
90 days
2

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

Time frame
3 years
3

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

Time frame
5 years
4

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

Clavien-Dindo IIIb and more measured as proportion

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Göteborg University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: