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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant SIB radiotherapy | Experimental | Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 36 months |
| Pattern of Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Chen, MD | Contact | 00861324000876 | chenboo@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bo Chen | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The type of recurrence (locoregional failures or distant failure)
| up to 36 months |
| Toxic Events | Toxic events was evaluated during received protocol therapy according to CTCAE 4.03 | up to 36 months |
| Local Control Rate | Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control. | up to 36 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |