Lateral lymph node recurrence in rectal cancer metastasised rectal cancer
Conditions
Interventions
Standardised radiotherapy and selective lateral lymph node dissection in high
risk patients.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - patients with rectal cancer - at least one enlarged lateral node; with a short-axis of *7mm on the iliac or obturator compartment, measured on MRI
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients younger than 18 years old - Patients with previous pelvic radiotherapy - Patients that have undergone a lateral lymph node dissection for a previous pelvic malignancy - Patients with synchronous distant metastases - Synchronous colon cancer with a higher stage than the rectal cancer - Other malignancies in the previous 3 years which could affect oncological outcomes (these patients must first be discussed with the research team before inclusion) - Patients with an absolute contra-indication for general anaesthesia - Patients with familiar adenomatous polyposis (FAP) - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether optimal irradiation and indicated lateral lymph node dissections (LLNDs) can reduce the lateral local recurrence rate to 6%, as described in the literature. Patients who cannot undergo nerve sparing LLND or minimally invasive TME due to the extensiveness of their tumor will drop out of the main cohort and enter the registration arm together with Asian patients treated in Asia who follow the exact same protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the morbidity, quality of life and functional quality of patients by questionnaires. | — |
Countries
Netherlands
Outcome results
None listed