Investigating Lateral Nodal Recurrence in Rectal Cancer
Lateral Nodal Recurrence in Rectal Cancer
This study looks at patients with rectal cancer and enlarged lymph nodes to see if removing those nodes helps prevent the cancer from coming back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT04486131 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with rectal cancer who have enlarged lateral lymph nodes, assessing the rates of local recurrence following treatment with total mesorectal excision and neoadjuvant (chemo)radiotherapy. It aims to analyze data collected from multiple centers over five years, specifically looking at the relationship between the size and characteristics of lateral pelvic nodes and the occurrence of local recurrence. The study seeks to enhance understanding of the effectiveness of lateral lymph node dissection in reducing recurrence rates in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with rectal cancer exhibiting one or more lateral nodes measuring ≥7mm or ≥5mm with malignant features.
Not a fit: Patients who have had previous pelvic irradiation or lateral lymph node dissection, or those with synchronous distant metastases, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for rectal cancer patients, potentially reducing local recurrence rates.
How similar studies have performed: Previous multi-center studies have shown promising results regarding the management of lateral lymph nodes in rectal cancer, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • All patients with rectal cancer with one or more lateral nodes with a short-axis of ≥7mm or ≥5mm with one or more malignant features (i.e. round shape, irregular margins, heterogeneity, loss of fatty hilum). Exclusion Criteria: * Younger than 18 years old * Pelvic irradiation in the medical history * Previous lateral lymph node dissection related to pelvic malignancy * Synchronous distant metastases * Familiar adenomatous polyposis * Synchronous colon cancer with a higher stage than rectal cancer * Absolute contraindication for general anaesthesia * Pregnancy
Where this trial is running
Amsterdam, North Holland
- Amsterdam University Medical Centers — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Miranda Kusters, MD, PhD — VUMedicalCentre
- Study coordinator: Miranda Kusters, MD, PhD
- Email: m.kusters@amsterdamumc.nl
- Phone: 0031204444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.