Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM) (TROG1703 LARK)

University of Sydney

Status: Active, not recruiting

Conditions: Liver Cancer

Treatments: Device: Kilovoltage Intrafraction Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02984566

TROG1703 LARK

Details and patient eligibility

About

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

Full description

This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG performance status 0-1
• Life expectancy >6 months
• Number of lesions: ≤ 3
• Lesion size : < 10 cm for a single lesion (and up to 10 cm cumulative diameter for multiple lesions)
• Child-Pugh A or B7 within 6 weeks prior to study entry
• Unsuitable for RFA or resection or transplant
• Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or large bowel) ≥ 10mm
• All blood work obtained within 6 weeks prior to study entry with adequate organ function
• May have had previous surgery, RFA or ethanol injection
• Patient must have been discussed at multidisciplinary tumour board with consensus opinion for SBRT

Exclusion criteria

• HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant metastases
• Metastatic disease with complete liver disease response to first-line chemotherapy (i.e. no target for SBRT)
• Previous radiation to the liver (including SIRTEX)
• Untreated HIV or active hepatitis B/C
• On systemic antineoplastic drug therapy within 7 days before inclusion
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

SABR with or without KIM

Experimental group

Description:

All patients will receive liver SABR. Kilovoltage Intrafraction Monitoring (KIM) tracking will be trialed during mock treatment. If KIM is successful, it will be used throughout treatment. If unsuccessful, cone beam CT will be used instead.

Treatment:

Device: Kilovoltage Intrafraction Monitoring