NCT04850027

MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 268 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Detailed description

Our study design is a multicenter, prospective, registry study. We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm. The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 \~ 50.5 Gy are recommended. The postoperative examination should be performed every three months in the first two years and every six months in the following three years. Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	TME+Lateral lymph node dissection.	TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2021-04-20
• Last updated: 2021-04-26

Locations

1 site across 1 country: China