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

Not Applicable

Recruiting

• Conditions: Hepatectomy; Hepatocellular Carcinoma; Radiotherapy
• Interventions: Radiation: Surgery-radiotherapy

• Registration Number: NCT03732105
• Lead Sponsor: Sun Yat-sen University

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 Timeline

• Study Start: 2018-08-08
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-04
• Study First Posted: 2018-11-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-08-11
• Study Completion: 2025-08-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Age 18 - 75 years.
2. HCC who underwent R0 resection with pathological confirmation.
3. The narrowest margin is less than or equal to 1 cm.
4. No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
5. ECOG PS ≤ 1.
6. Child-Pugh score 5-7.
7. Expected life expectancy ≥ 6 months.
8. Blood, liver, and kidney functions meet the following criteria: 1)Neutrophil counts ≥ 1.5×109/L; 2)Platelet counts ≥ 60×109/L; 3)Hemoglobin concentration ≥ 90g/L; 4)Serum albumin concentration ≥ 30g/L; 5)Bilirubin ≤ 1.5 × upper limit of normal; 6)AST and ALT < 3× ULN; 7)Extended prothrombin time not exceeding 3s of ULN; 8)Creatinine < 1.5× ULN.

Exclusion Criteria

1. Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
2. The number of tumors ≥4.
3. Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
4. Patients with concomitant HIV or syphilis infection.
5. Patients with concurrent or other malignancies within 5 years before enrollment.
6. Patients receiving allogeneic organ transplantation.
7. Patients with severe dysfunction of the heart, kidneys or other organs.
8. Participated in clinical trials of other drugs within 12 months before enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery-radiotherapy	Surgery-radiotherapy	Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after surgery. After radiotherapy, patients will be actively monitored.

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival,RFS	two years	Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.

Secondary Outcome Measures

Name	Time	Method
Time To Recurrence, TTR	two years	Defined as the time from randomization until disease recurrence.
Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).	two years	Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4)causality of Adverse Events (AEs) during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).
health related quality of life	two years	The quality of life is accessed by EORTC QLQ-C30 (version 3).
Overall Survival, OS	two years	Defined as the time from randomization until death from any cause.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China