Stereotactic ablative body radiotherapy (SABR) for Liver Cancer After Radiology treatment (TACE)

Not Applicable

Active, not recruiting

• Conditions: Hepatocellular Carcinoma; Cancer - Liver

• Registration Number: ACTRN12616001697471
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

INCLUSION CRITERIA
Aged > 18 years
Able to give informed consent
ECOG 0-1
Barcelona clinic liver cancer (BCLC) class A/B as determined by a Hepatocellular Carcinoma Multidisciplinary team (HCC MDT)
HCC diagnosed by standard radiological criteria or histology
HCC < 6cm which is amenable to SABR
Pre-treated with TACE with incomplete response or re-occurrence
Measureable disease on imaging defined by M RECIST criteria

Exclusion Criteria

EXCLUSION CRITERIA
BCLC C (significant decompensated liver disease or HCC not amenable to TACE)
Significant comorbidities unable to safely tolerate sedation/anaesthetic
Expected life expectancy of < 24 months
Prior radiotherapy to abdomen
Pregnant or lactating (any woman of childbearing potential must have a pregnancy test prior to enrollment and must take adequate precautions to prevent pregnancy during treatment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Persistent tumour or local recurrence<br><br>Tumour growth characteristics and local recurrence will be determined by using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and imaging studies.<br>Modalities (CT/MRI) will be determined by the HCC MDT at the Royal Adelaide Hospital.<br><br> <br><br>[Persistent tumour or local recurrence will be measured at 1, 3, 6, 9, 12, 18 and 24 months after the completion of treatment.];(2) New development of distant metastasis during this study.<br><br>Tumour growth characteristics and distal metastasis will be determined by Response Evaluation Criteria In Solid Tumors (RECIST) and imaging studies.<br>Modalities (CT/MRI) will be determined by the HCC MDT at the Royal Adelaide Hospital.[The development of new or distant metastasis will be measured during this study at 1, 3, 6, 9, 12, 18 and 24 months after the completion of treatment.]

Secondary Outcome Measures

Name	Time	Method
(1) Progression of MELD - The Model for End Stage Liver Disease (MELD) will be used to predict survival for patients with advanced liver disease.<br><br>[The progression of MELD will be calculated at 1, 3, 6, 9, 12, 18 and 24 months after the completion of treatment or primary end point is reached.];(2) Progression of Child’s Pugh Score. The Child-Turcotte-Pugh Classification for Severity of Cirrhosis will be used to estimate the child's cirrhosis severity. [The progression of Child’s Pugh Score will be calculated at 1, 3, 6, 9, 12, 18 and 24 months after the completion of treatment or primary end point is reached.]