CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis
NCT ID: NCT04512833
Last Updated: 2023-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2020-08-12
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Cyberknife stereotactic body radiation therapy
A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.
Eligibility Criteria
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Inclusion Criteria
* Unfeasible or refusing to undergo other treatments;
* Residual normal liver volume ≥700 cc;
* With decompensated cirrhosis (Child-Pugh B or C classification);
* Without portal vein tumor thrombus;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；
* Rejecting other therapies such as resection, liver transplantation, etc.
* Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
* Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.
Exclusion Criteria
* With extrahepatic metastasis;
* With lymph node involvement.
30 Years
80 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Locations
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Beijing 302 hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 10.3389/fonc.2020.00100. eCollection 2020.
Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3.
Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1.
Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28.
Other Identifiers
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decompensated cirrhosis HCC
Identifier Type: -
Identifier Source: org_study_id
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