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

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ClinicalTrials.gov Identifier: NCT02984566
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sydney

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

Condition or disease Intervention/treatment Phase
Liver Cancer Device: Kilovoltage Intrafraction Monitoring Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SABR with or without KIM
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984566


Contacts
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Contact: Doan Nguyen, PhD +61 2 8627 1185 d.nguyen@sydney.edu.au
Contact: Natalie Plant, Masters +61 2 8627 1133 natalie.plant@sydney.edu.au

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2049
Contact: Tracy Pearl-Larsson    02 8890 5200    Tracy.Pearl-Larson@health.nsw.gov.au   
Principal Investigator: Tim Wang         
Sponsors and Collaborators
University of Sydney
Investigators
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Principal Investigator: Tim Wang, Dr Westmead Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02984566    
Other Study ID Numbers: TROG1703 LARK
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
Primary liver cancer
Secondary liver cancer
Kilovoltage Intrafraction Monitoring
Stereotactic Ablative Body Radiation
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases