Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02984566

Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nepean Hospital, Penrith, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kilovoltage Intrafraction Monitoring

Device

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.

Primary outcomes

  1. Difference in accumulated patient dose distribution with and without KIM

    Time frame: 15-60 minutes (time of individual fraction delivery)

    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

Secondary outcomes

  1. Difference in treatment time with and without KIM

    Time frame: 15-60 minutes (time of individual fraction delivery)

    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

  2. Difference in imaging dose with and without KIM

    Time frame: 15-60 minutes (time of individual fraction delivery)

    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

  3. Difference in PTV margins with and without KIM

    Time frame: 15-60 minutes (time of individual fraction delivery)

    The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.

  4. Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans

    Time frame: 15-60 minutes (time of individual fraction delivery)

    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.

  5. Change in dose when using KIM with and without using MLC tracking

    Time frame: 15-60 minutes (time of individual fraction delivery

    Difference between dose delivered using KIM with or without MLC tracking

  6. Proportion of local failures at two years for patients treated

    Time frame: 2 years

    Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria

  7. The proportion of grade 3 or higher toxicities

    Time frame: 2 years

    The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03

  8. 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)

    Time frame: 2 years

    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.

  9. 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)

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Registry information

Official study title

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

Acronym: TROG1703 LARK

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2016
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.