Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT03732105
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2018-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: