Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
- Conditions
- Liver Cancer
- Interventions
- Device: Kilovoltage Intrafraction Monitoring
- Registration Number
- NCT02984566
- Lead Sponsor
- University of Sydney
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SABR with or without KIM Kilovoltage Intrafraction Monitoring 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.
- Primary Outcome Measures
Name Time Method Difference in accumulated patient dose distribution with and without KIM 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
Name Time Method Difference in treatment time with and without KIM 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
Proportion of local failures at two years for patients treated 2 years Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria
Difference in PTV margins with and without KIM 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.
Change in dose when using KIM with and without using MLC tracking 15-60 minutes (time of individual fraction delivery Difference between dose delivered using KIM with or without MLC tracking
Difference in imaging dose with and without KIM 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
Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans 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.
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) 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.
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) 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.
The proportion of grade 3 or higher toxicities 2 years The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
Trial Locations
- Locations (4)
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Nepean Hospital
🇦🇺Penrith, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia