Rectal Neoplasm Malignant
Conditions
Keywords
lateral lymph nodes, Quality of life, local recurrence, thrombosis, lymph oedema, lateral lymph node dissection
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.
Interventions
PROCEDURELateral lymph node dissection
Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue
Sponsors
Göteborg University
Sahlgrenska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Lateral local recurrence | 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 |
| Surgical morbidity (including reoperations) (Clavien Dindo score I-V) | 90 days | Clavien-Dindo IIIb and more measured as proportion |
| Surgical morbidity measured as Comprehensive Complications index (lower score = less complications) | 90 days | All complications registered according to Clavien-Dindo using a calculator to identify a combination of the number and the severity of complications. |
| Perioperative blood loss | 0-24 hours | Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist) |
| Total operating time | 0-24 hours | Registration in operative CRF (op start and op end) |
| Length of hospital stay | 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 |
| Total length of hospital stay | 365 days = 1 year | Total number of days including readmissions |
| Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) | 1 year | Clinical or radiological or patient reported thromobsis |
| Health related Quality of life | 1 month postop | Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL. |
| Urinary function | 1 month | Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach. |
| Sexual function | 1 year | Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach. |
| Complications according to a composite outcome | 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 |
| Health economic analysis | 1 year | A total health economic analysis including societal costs |
| Mortality | 1 year | Dead by any cause |
| 5- year overall survival | 5 years | Survival at 5 years |
| Pain according to brief pain inventory | 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 |
| MRI interobserver variability | First month | Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment |
| MRI vs pathology | First 6 months | Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report |
| ctDNA at diagnosis | Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence | Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes |
| Value of immunoscore to predict response, and presence of lateral lymph nodes | 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 |
| Evaluation dose/fraction in relation to response to treatment | Within the first 6 months. | Details from CRF during treatment planning as well as prospectively collected treatment plans |
| Evaluation of number of fractions n relation to response to treatment | Within the first 6 months | Details from CRF during treatment planning as well as prospectively collected treatment plans |
| Evaluation of final dose to tumor and elective LN volume | Within the first 6 months | Details from CRF during treatment planning as well as prospectively collected treatment plans |
| Bowel and stoma function | 1 year | Measured in QoL questionnaire, major LARS (21-42 points) |
Countries
Sweden
Contacts
Primary ContactEva Angenete, MD PhD
Outcome results
None listed