Clinical trial NCT03988998: Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma
Official title: radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radiofrequency Ablation with or without Radiotherapy
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: the 2-years recurrence rate
timeFrame: 2 year
Secondary outcomes:
measure: the 2-years recurrence-free survival
timeFrame: 2 year
measure: the 2-years overall survival.
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Guangxi Medical University
name: Tang Wei-Zhong, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.