Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Adjuvant SIB radiotherapy

    Radiation

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adjuvant SIB radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 36 months

Secondary outcomes

1

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

Time frame
up to 36 months
2

Pattern of Failure

The type of recurrence (locoregional failures or distant failure)

Time frame
up to 36 months
3

Toxic Events

Toxic events was evaluated during received protocol therapy according to CTCAE 4.03

Time frame
up to 36 months
4

Local Control Rate

Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control.

Time frame
up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.