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出境医 / 临床实验 / Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Study Description
Brief Summary:
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Radiofrequency ablation with radiotherapy Drug: Radiofrequency ablation alone Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Radiofrequency Ablation with or without Radiotherapy
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes (recurrence or death) Assessor is blind about the interventions.
Primary Purpose: Treatment
Official Title: radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
Estimated Study Start Date : August 10, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Radiofrequency ablation with radiotherapy
Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.
 Drug: Radiofrequency ablation with radiotherapy
Radiofrequency ablation with radiotherapy
Active Comparator: Radiofrequency ablation alone
Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.
 Drug: Radiofrequency ablation alone
Radiofrequency ablation without radiotherapy
Outcome Measures
Primary Outcome Measures :
  1. the 2-years recurrence rate [ Time Frame: 2 year ]
    Two year recurrence rate between the two groups will be compared.


Secondary Outcome Measures :
  1. the 2-years recurrence-free survival [ Time Frame: 2 year ]
    Two year recurrence-free survival between the two groups will be compared.

  2. the 2-years overall survival. [ Time Frame: 2 year ]
    Two year overall survival between the two groups will be compared.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnoses of hepatocellular carcinoma based on EASL.
  2. Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
  3. Patients must have a performance status of ECOG score < 2.

  4. Patients must have adequate liver reservation and adequate hemogram.

    • Pugh-Child's Score < 7.
    • The serum total bilirubin level are < 2 mg/dl.
    • The prothrombin times are < 3 sec above normal control.
    • The platelet are > 75 x 109/L.
  5. Patient must have serum creatinine < 1.5 mg/dl
  6. Cardiac function with NYHA classification < Grade II
  7. HBsAg (+) .
  8. Signed informed consent.

Exclusion Criteria:

  1. HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
  2. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
  3. Patients with advanced second primary malignancy are not eligible.
  4. Patients with pregnancy or breast-feeding are not eligible.
  5. Patients with severe cardiopulmonary diseases are not eligible.
  6. Patients with clinically significant psychiatric disorder are not eligible.
  7. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
  8. Patients who had prior antitumor therapy for HCC are not eligible.
  9. Anti-HCV positive patients are not eligible.
Contacts and Locations

Contacts
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Contact: Zhong Jian-Hong, PhD 0771-5301253 zhongjianhong@gxmu.edu.cn
Contact: Xiang Bang-De, PhD 0771-5301253 xiangbangde@gxmu.edu.cn

Sponsors and Collaborators
Guangxi Medical University
Investigators
Layout table for investigator information
Study Chair: Tang Wei-Zhong, PhD Guangxi Medical University
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE August 10, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2019) 		the 2-years recurrence rate [ Time Frame: 2 year ]
Two year recurrence rate between the two groups will be compared.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2019)
  • the 2-years recurrence-free survival [ Time Frame: 2 year ]
    Two year recurrence-free survival between the two groups will be compared.
  • the 2-years overall survival. [ Time Frame: 2 year ]
    Two year overall survival between the two groups will be compared.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma
Official Title  ICMJE radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
Brief Summary Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Radiofrequency Ablation with or without Radiotherapy
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes (recurrence or death) Assessor is blind about the interventions.
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Radiofrequency ablation with radiotherapy
    Radiofrequency ablation with radiotherapy
  • Drug: Radiofrequency ablation alone
    Radiofrequency ablation without radiotherapy
Study Arms  ICMJE
  • Experimental: Radiofrequency ablation with radiotherapy
    Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.
    Intervention: Drug: Radiofrequency ablation with radiotherapy
  • Active Comparator: Radiofrequency ablation alone
    Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.
    Intervention: Drug: Radiofrequency ablation alone
Publications *
  • Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.
  • Seo YS, Kim MS, Yoo HJ, Jang WI, Paik EK, Han CJ, Lee BH. Radiofrequency ablation versus stereotactic body radiotherapy for small hepatocellular carcinoma: a Markov model-based analysis. Cancer Med. 2016 Nov;5(11):3094-3101. doi: 10.1002/cam4.893. Epub 2016 Oct 5. Review.
  • Hara K, Takeda A, Tsurugai Y, Saigusa Y, Sanuki N, Eriguchi T, Maeda S, Tanaka K, Numata K. Radiotherapy for Hepatocellular Carcinoma Results in Comparable Survival to Radiofrequency Ablation: A Propensity Score Analysis. Hepatology. 2019 Jun;69(6):2533-2545. doi: 10.1002/hep.30591. Epub 2019 May 2.
  • Kim N, Kim HJ, Won JY, Kim DY, Han KH, Jung I, Seong J. Retrospective analysis of stereotactic body radiation therapy efficacy over radiofrequency ablation for hepatocellular carcinoma. Radiother Oncol. 2019 Feb;131:81-87. doi: 10.1016/j.radonc.2018.12.013. Epub 2018 Dec 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinical diagnoses of hepatocellular carcinoma based on EASL.
  2. Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
  3. Patients must have a performance status of ECOG score < 2.

  4. Patients must have adequate liver reservation and adequate hemogram.

    • Pugh-Child's Score < 7.
    • The serum total bilirubin level are < 2 mg/dl.
    • The prothrombin times are < 3 sec above normal control.
    • The platelet are > 75 x 109/L.
  5. Patient must have serum creatinine < 1.5 mg/dl
  6. Cardiac function with NYHA classification < Grade II
  7. HBsAg (+) .
  8. Signed informed consent.

Exclusion Criteria:

  1. HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
  2. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
  3. Patients with advanced second primary malignancy are not eligible.
  4. Patients with pregnancy or breast-feeding are not eligible.
  5. Patients with severe cardiopulmonary diseases are not eligible.
  6. Patients with clinically significant psychiatric disorder are not eligible.
  7. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
  8. Patients who had prior antitumor therapy for HCC are not eligible.
  9. Anti-HCV positive patients are not eligible.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhong Jian-Hong, PhD 0771-5301253 zhongjianhong@gxmu.edu.cn
Contact: Xiang Bang-De, PhD 0771-5301253 xiangbangde@gxmu.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988998
Other Study ID Numbers  ICMJE FARTHER
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian-Hong Zhong, Guangxi Medical University
Study Sponsor  ICMJE Guangxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tang Wei-Zhong, PhD Guangxi Medical University
PRS Account Guangxi Medical University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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