About this trial
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)
Age > 18 years
Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
Child-Push Score: A5-A6
Disqualifiers
History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
Had prior abdominal irradiation
Had prior liver transplantation
Had serious myocardial disease or renal failure
Trial design
Single group
Treatments tested in this trial
Adjuvant SIB radiotherapy
RadiationEligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs.
Treatment groups
Trial outcomes
Primary outcomes
The 3-year Overall Survival
The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
Secondary outcomes
Disease-free Survival (DFS)
Disease-free survival (DFS) was calculated from the date of surgical resection to the date of the first recurrence or death from HCC
Pattern of Failure
The type of recurrence (locoregional failures or distant failure)
Toxic Events
Toxic events was evaluated during received protocol therapy according to CTCAE 4.03
Local Control Rate
Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control.
Sponsors and contacts
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