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

NCT03732105 | Recruiting DMC

• 1 other identifier: 2018175
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Radiotherapy; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival,RFS

  Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.

  two years

Secondary Outcomes (4)

• Overall Survival, OS

  two years

• Time To Recurrence, TTR

  two years

• Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).

  two years

• health related quality of life

  two years

Study Arms (2)

Surgery-radiotherapy

EXPERIMENTAL

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.

Radiation: Surgery-radiotherapy

Surgery group

NO INTERVENTION

Patients in the surgery group will be actively monitored after randomization.

Interventions

Surgery-radiotherapy RADIATION

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

Surgery-radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangzhou Medical University: collaborator
• Southern Medical University, China: collaborator
• Shantou University Medical College: collaborator

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related 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/s10434-012-2513-1. Epub 2012 Nov 13.

  PMID: 23149850 RESULT

• 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 vessels. Liver Int. 2015 Dec;35(12):2603-10. doi: 10.1111/liv.12857. Epub 2015 Jun 3.

  PMID: 25939444 RESULT

• 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/j.jamcollsurg.2013.11.030. Epub 2013 Dec 2.

  PMID: 24559953 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ming Kuang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Kuang, PhD

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: August 8, 2018
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (1)