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

Who is this study for? Patients who underwent curative resection with postoperative pathology diagnosed as hepatocellular carcinoma with microvascular invasion
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18 - 75 years.

• HCC who underwent R0 resection with pathological confirmation.

• The narrowest margin is less than or equal to 1 cm.

• No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.

• ECOG PS ≤ 1.

• Child-Pugh score 5-7.

• Expected life expectancy ≥ 6 months.

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Ming Kuang, PhD
kuangm@mail.sysu.edu.cn
008687755766
Time Frame
Start Date: 2018-08-08
Estimated Completion Date: 2025-08-11
Participants
Target number of participants: 148
Treatments
Experimental: 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.
No_intervention: Surgery group
Patients in the surgery group will be actively monitored after randomization.
Related Therapeutic Areas
Sponsors
Collaborators: Southern Medical University, China, Guangzhou Medical University, Shantou University Medical College
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov