Hepatocellular Carcinoma, Narrow Margin, Radiotherapy
Conditions
Keywords
Hepatocellular Carcinoma, Narrow Margin, Adjuvant Simultaneously Integrated Boost Radiotherapy
Brief 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.
Detailed description
Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(\<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC.
Interventions
RADIATIONAdjuvant SIB radiotherapy
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 3-year Overall Survival | up to 36 months | The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) | up to 36 months | 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 | up to 36 months | The type of recurrence (locoregional failures or distant failure) |
| Toxic Events | up to 36 months | Toxic events was evaluated during received protocol therapy according to CTCAE 4.03 |
| Local Control Rate | up to 36 months | Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control. |
Countries
China
Contacts
Primary ContactBo Chen, MD
Outcome results
None listed