Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Liver Cancer Clinical Trial

— TROG1703 LARK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02984566
• Other study ID #: TROG1703 LARK
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Kilovoltage Intrafraction Monitoring
KIM is a novel intrafraction real-time tumour localization method. It involves a single gantry-mounted kV x-ray imager acquiring 2D projections of implanted fiducial markers. 3D positions are then reconstructed by maximum likelihood estimation of a 3D probability density function.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Nepean Hospital	Penrith	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in accumulated patient dose distribution with and without KIM	Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The planning CT scan will be used for this assessment	15-60 minutes (time of individual fraction delivery)
Secondary	Difference in treatment time with and without KIM	The time taken for the KIM treatments compared with the time taken for similar treatments from previous patients, accounting for the difference in the time and number of patient images acquired and the time taken to adjust the patient's position during treatment	15-60 minutes (time of individual fraction delivery)
Secondary	Difference in imaging dose with and without KIM	The KIM procedure adds radiation dose with the kilovoltage images. However, there may be fewer volumetric cone beam computed tomography (CBCT) scans acquired. This difference in dose will be estimated and analysed	15-60 minutes (time of individual fraction delivery)
Secondary	Difference in PTV margins with and without KIM	The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.	15-60 minutes (time of individual fraction delivery)
Secondary	Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans	Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The intratreatment CBCT scans will be used for this assessment.	15-60 minutes (time of individual fraction delivery)
Secondary	Change in dose when using KIM with and without using MLC tracking	Difference between dose delivered using KIM with or without MLC tracking	15-60 minutes (time of individual fraction delivery
Secondary	Proportion of local failures at two years for patients treated	Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria	2 years
Secondary	The proportion of grade 3 or higher toxicities	The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03	2 years
Secondary	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)	To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12, 18 and 24 months post-radiation therapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). The questionnaire will be self-administered and will be given in patient's mother tongue.	2 years
Secondary	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)	To compare change in Quality of Life related to hepatocellular carcinoma (HCC) as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12 and 18 months post-radiation therapy. The questionnaire will be self-administered and will be given to patients proficient in English. EORTC-QLQ-HCC18: includes HCC-specific symptoms or problems. Questions used 4-point Likert scale from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.	18 months