NCT04991090

Management of LLN Metastasis in Locally Advanced Rectal Cancer: A Prospective Radiation Dose Escalation Study

Management of Clinically Involved Lateral Lymph Node Metastasis in Locally Advanced Rectal Cancer: A Prospective Radiation Dose Escalation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, locally advanced rectal cancer (LARC) patients with lateral lymph node (LLN) metastasis would be enrolled. The LLNs with short axis (SA) ≥ 5 mm are considered metastatic.The safety of neoadjuvant chemoradiotherapy(nCRT) with a booster dose to 58Gy had been initially demonstrated in our previous research. The effective and safety of dose escalation of LLN in LARC patients, will be further verified in this prospective, clinical study.

Detailed description

This is a prospective, observational clinical study for validation the efficiency and safety of the dose escalation of LLN. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical T1-4N1-2M0 without distant metastasis will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University. Patients should have at least one LLN metastasis defined on primary MRI, and the data of primary pelvic MRI will be performed within two weeks before the beginning of enrollment. All patients should follow a standard treatment protocol, including concurrent neoadjuvant chemoradiotherapy (nCRT) with a dose boost of LLNs to 58Gy, TME surgery with or without LLND ( lateral lymph node dissection) and adjuvant chemotherapy. The regimen of chemotherapy and the way of operation should be depended on the MDT(multiply discipline treatment) decision. The restaged MRI scan would be performed 6-12 weeks after the last fraction of radiotherapy. The LLN response rate ( short axis \< 5mm ) would be evaluated. This study is aimed to apply a new way to control LLN metastasis.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	escalation dose of LLNs	The lymph nodes (SA ≥ 5 mm) existed at the internal iliac and obturator would be delineated, named as GTVnd, and received a radiation dose boost of 58Gy.

Timeline

• Start date: 2021-08-13
• Primary completion: 2024-08-01
• Completion: 2024-08-28
• First posted: 2021-08-05
• Last updated: 2022-11-23

Locations

1 site across 1 country: China