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

Primary Purpose

Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Kilovoltage Intrafraction Monitoring
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Primary liver cancer, Secondary liver cancer, Kilovoltage Intrafraction Monitoring, Stereotactic Ablative Body Radiation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nepean HospitalRecruiting
  • Westmead HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Peter MacCallum Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SABR with or without KIM

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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.
Change in dose when using KIM with and without using MLC tracking
Difference between dose delivered using KIM with or without MLC tracking
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
The proportion of grade 3 or higher toxicities
The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
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.
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.

Full Information

First Posted
November 23, 2016
Last Updated
January 23, 2023
Sponsor
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02984566
Brief Title
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Acronym
TROG1703 LARK
Official Title
LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Primary liver cancer, Secondary liver cancer, Kilovoltage Intrafraction Monitoring, Stereotactic Ablative Body Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SABR with or without KIM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kilovoltage Intrafraction Monitoring
Intervention Description
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 Measure Information:
Title
Difference in accumulated patient dose distribution with and without KIM
Description
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
Time Frame
15-60 minutes (time of individual fraction delivery)
Secondary Outcome Measure Information:
Title
Difference in treatment time with and without KIM
Description
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
Time Frame
15-60 minutes (time of individual fraction delivery)
Title
Difference in imaging dose with and without KIM
Description
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
Time Frame
15-60 minutes (time of individual fraction delivery)
Title
Difference in PTV margins with and without KIM
Description
The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.
Time Frame
15-60 minutes (time of individual fraction delivery)
Title
Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans
Description
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.
Time Frame
15-60 minutes (time of individual fraction delivery)
Title
Change in dose when using KIM with and without using MLC tracking
Description
Difference between dose delivered using KIM with or without MLC tracking
Time Frame
15-60 minutes (time of individual fraction delivery
Title
Proportion of local failures at two years for patients treated
Description
Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria
Time Frame
2 years
Title
The proportion of grade 3 or higher toxicities
Description
The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
Time Frame
2 years
Title
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)
Description
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.
Time Frame
2 years
Title
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)
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doan Nguyen, PhD
Phone
+61 2 8627 1185
Email
d.nguyen@sydney.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Plant, Masters
Phone
+61 2 8627 1133
Email
natalie.plant@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Wang, Dr
Organizational Affiliation
Westmead Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten van Gysen
First Name & Middle Initial & Last Name & Degree
Kirsten van Gysen
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2049
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Pearl-Larsson
Phone
02 8890 5200
Email
Tracy.Pearl-Larson@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Tim Wang
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo Young Lee
First Name & Middle Initial & Last Name & Degree
Yoo Young Lee
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Chu
First Name & Middle Initial & Last Name & Degree
Julie Chu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.
Citations:
PubMed Identifier
33941111
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.
Results Reference
derived

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Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

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