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

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ClinicalTrials.gov Identifier: NCT02984566
Recruitment Status : Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sydney

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.




Primary Outcome Measures :
  1. Quantify accumulated patient dose distribution with the KIM intervention compared to dose distribution estimated without the KIM intervention. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quantitative assessment of treatment time. [ Time Frame: 2 years ]
  2. Quantitative assessment of imaging dose. [ Time Frame: 2 years ]
  3. Quantitative assessment of PTV margins. [ Time Frame: 2 years ]
  4. Quantitative assessment of cone-beam CT dose reconstruction. [ Time Frame: 2 years ]
  5. Quantitative assessment of dose reduction with MLC tracking [ Time Frame: 2 years ]
  6. Patient treatment outcome [ Time Frame: 2 years ]
    Determined by assessing local failure (as per modified RECIST criteria).

  7. Patient treatment outcome [ Time Frame: 30 days and 2 years ]
    Determined by assessing acute and late toxicity grade 3 or higher (as per CTCAE v4.03).

  8. Patient treatment outcome [ Time Frame: 4-6 weeks and 4, 8, 12, 18, and 24 months after treatment ]
    Determined by reviewing patient-reported outcomes on completion of radiation therapy, and at set time points after treatment.



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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

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: Shona Silvester, Masters shona.silvester@sydney.edu.au

Sponsors and Collaborators
University of Sydney
Investigators
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Principal Investigator: Tim Wang, Dr Westmead Hospital

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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02984566     History of Changes
Other Study ID Numbers: LARKV1
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
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
Liver Extracts
Hematinics