Hepatectomy, Hepatocellular Carcinoma, Radiotherapy
Conditions
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.
Interventions
RADIATIONSurgery-radiotherapy
Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization.
Sponsors
Guangzhou Medical University
Southern Medical University, China
Shantou University Medical College
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival,RFS | two years | Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival, OS | two years | Defined as the time from randomization until death from any cause. |
| 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). |
Countries
China
Contacts
Primary ContactMing Kuang, PhD
Outcome results
None listed