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

Hepatocellular Carcinoma Clinical Trial

— RAISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732105
• Other study ID #: 2018175
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: August 11, 2025

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: Ming Kuang, PhD
• Phone: 008687755766
• Email: kuangm[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: August 11, 2025
• Est. primary completion date: August 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatectomy
• Hepatocellular Carcinoma
• Radiotherapy

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou Medical University, Shantou University Medical College, Southern Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Rodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-0 — View Citation

Wang WH, Wang Z, Wu JX, Zhang T, Rong WQ, Wang LM, Jin J, Wang SL, Song YW, Liu YP, Ren H, Fang H, Wang WQ, Liu XF, Yu ZH, Li YX. Survival benefit with IMRT following narrow-margin hepatectomy in patients with hepatocellular carcinoma close to major vesse — View Citation

Yu W, Wang W, Rong W, Wang L, Xu Q, Wu F, Liu L, Wu J. Adjuvant radiotherapy in centrally located hepatocellular carcinomas after hepatectomy with narrow margin (<1 cm): a prospective randomized study. J Am Coll Surg. 2014 Mar;218(3):381-92. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival,RFS	Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.	two years
Secondary	Overall Survival, OS	Defined as the time from randomization until death from any cause.	two years
Secondary	Time To Recurrence, TTR	Defined as the time from randomization until disease recurrence.	two years
Secondary	Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).	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).	two years
Secondary	health related quality of life	The quality of life is accessed by EORTC QLQ-C30 (version 3).	two years