NCT03732105

Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)

Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.

Detailed description

RAISE trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). Random assignment was stratified by the condition of MVI and tumor size. All patients in the surgery-radiotherapy group received Intensity Modulated Radiation Therapy (IMRT) within 1-3 months after surgical resection. The prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. The trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.

Conditions

• Hepatocellular Carcinoma
• Radiotherapy
• Hepatectomy

Interventions

Type	Name	Description
RADIATION	Surgery-radiotherapy	Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization.

Timeline

• Start date: 2018-08-08
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2018-11-06
• Last updated: 2024-04-18

Locations

1 site across 1 country: China