Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
100 participants
Jan 26, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria10
- 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
- Estimated life expectancy \> 3 months
- No distant metastasis (M0)
- Blood routine examination: Hb≥80g/L, ANC≥1.0x10\^9/L, PLT≥50x10\^9/L
- Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
- Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
- Voluntary to participate and sign informed consent
Exclusion Criteria6
- 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
- Had moderate or severe ascites with obvious symptoms
- Duration from surgery ≥ 3 months
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06205472