Clinical trial NCT02984566: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Official title: LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Cancer
Keywords: Primary liver cancer
Secondary liver cancer
Kilovoltage Intrafraction Monitoring
Stereotactic Ablative Body Radiation
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in accumulated patient dose distribution with and without KIM
timeFrame: 15-60 minutes (time of individual fraction delivery)
Secondary outcomes:
measure: Difference in treatment time with and without KIM
timeFrame: 15-60 minutes (time of individual fraction delivery)
measure: Difference in imaging dose with and without KIM
timeFrame: 15-60 minutes (time of individual fraction delivery)
measure: Difference in PTV margins with and without KIM
timeFrame: 15-60 minutes (time of individual fraction delivery)
measure: Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans
timeFrame: 15-60 minutes (time of individual fraction delivery)
measure: Change in dose when using KIM with and without using MLC tracking
timeFrame: 15-60 minutes (time of individual fraction delivery
measure: Proportion of local failures at two years for patients treated
timeFrame: 2 years
measure: The proportion of grade 3 or higher toxicities
timeFrame: 2 years
measure: Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
timeFrame: 2 years
measure: Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC18)
timeFrame: 18 months
Other outcomes:
Locations:
city: Penrith
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Westmead Hospital
name: Tim Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YYD, Nguyen DT, Moodie T, O'Brien R, McMaster A, Hickey A, Pritchard N, Poulsen P, Tabaksblat EM, Weber B, Worm E, Pryor D, Chu J, Hardcastle N, Booth J, Gebski V, Wang T, Keall P. Study protocol of the LARK (TROG 17.03) clinical trial: a phase II trial investigating the dosimetric impact of Liver Ablative Radiotherapy using Kilovoltage intrafraction monitoring. BMC Cancer. 2021 May 3;21(1):494. doi: 10.1186/s12885-021-08184-x.