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Trial registered on ANZCTR


Registration number
ACTRN12621001634864
Ethics application status
Approved
Date submitted
1/10/2021
Date registered
29/11/2021
Date last updated
17/11/2022
Date data sharing statement initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Swelling following Radiation Therapy for Non-Melanoma Skin Cancer of the Legs.
Scientific title
EVOLVE: Evaluation of Oedema and Lymphatic Function following Volumetric Modulated Arc Therapy for Non-melanoma Extensive Skin Field Cancerisation of the Lower Limbs
Secondary ID [1] 305228 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EVOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Melanoma Skin Cancer 323507 0
Condition category
Condition code
Cancer 321068 321068 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational study which aims to utilise validated assessment tools for patients undergoing VMAT radiation for skin field cancerisation of the lower limbs to explore factors which may impact oedema and lymphatic drainage. Assessments include medical history, circumferential limb measures, cone beam computed tomography (CBCT) volume measures, radiation dosimetry, bioimpedance spectroscopy, indocyanine green (ICG) lymphography and patient reported outcome surveys. Participants will attend 2 ICG lymphography scans pre radiation therapy and 6 months after completing radiation therapy which will take approximately one hour. During treatment the participants will be seen after their radiation therapy weekly for circumferential and bioimpedance spectroscopy measures and to complete patient reported outcome surveys which will take approximately half an hour. After treatment is completed the participants will be seen for the same measures and surveys one, two and six weeks, and three and six months post treatment after consultation with their radiation oncologist.
Intervention code [1] 321627 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328846 0
Limb volume changes using circumferential measures at 4cm increments during and up to 6-months post VMAT
Timepoint [1] 328846 0
Pre-treatment, after 5, 10, 15, 20 and 25 fractions, weekly during treatment break, 1, 2 and 6 weeks post treatment, 3 and 6 months post treatment.
Secondary outcome [1] 400628 0
Lymphoedema severity ascertained by indocyanine green (ICG) lymphography using MD Anderson Cancer Center (MDACC) lymphoedema staging scale.
Timepoint [1] 400628 0
Baseline and 6 months post treatment
Secondary outcome [2] 400629 0
Below knee limb volume calculated by cone beam computed tomography (CBCT) and circumference measures (4cm and 10cm increments)
Timepoint [2] 400629 0
Baseline and after 5, 10, 15, 20 and 25 fractions
Secondary outcome [3] 400630 0
To determine the percent limb volume change which will reduce PTV coverage of D98% to <95% assessed using cone beam computed tomography (CBCT) scans merged with the original planning computed tomography (CT) scans in the treatment planning system. Limb volume will be calculated from circumferential measures and recorded in the electronic data management system. These volume measures will be correlated to PTV coverage.
Timepoint [3] 400630 0
PTV coverage and limb volume will be calculated after 5, 10, 15, 20 and 25 fractions
Secondary outcome [4] 400631 0
Limb volume calculated from circumferential measures

Timepoint [4] 400631 0
Limb volume calculated by circumferential limb measurements will be recorded pre-treatment, after 5, 10, 15, 20 and 25 fractions, weekly during radiation therapy treatment break, 1, 2 and 6 weeks post radiation therapy treatment, 3 and 6 months post radiation therapy treatment.
Secondary outcome [5] 400632 0
Patient reported outcomes determined by Lymphoedema Symptom Intensity and Distress Survey (leg) (LSIDS-leg) survey. LSIDS-leg surveys will be collected by research staff and recorded in the electronic data management system.
Timepoint [5] 400632 0
LSIDS-leg surveys will be recorded at baseline, end of radiation therapy treatment break, end of radiation therapy treatment, 3 and 6 months post radiation therapy treatment
Secondary outcome [6] 402340 0
Patient reported outcomes determined by Lower Limb Core Scale (LLCS) survey. LLCS surveys will be collected by research staff and recorded in the electronic data management system.
Timepoint [6] 402340 0
Lower Limb Core Scale (LLCS) recorded at baseline, after 5, 10, 15, 20 and 25 fractions, weekly during radiation therapy treatment break, 1, 2 and 6 weeks post radiation therapy treatment, 3 and 6 months post radiation therapy treatment.
Secondary outcome [7] 402341 0
Patient reported outcomes determined by the Rapid Assessment of Physical Activity (RAPA) survey. RAPA surveys will be collected by research staff and recorded in the electronic data management system.
Timepoint [7] 402341 0
The RAPA survey will be recorded at baseline, end of treatment and 6 months post treatment
Secondary outcome [8] 403133 0
Bioimpedance spectrocopy (BIS) measured using the ImediMed SOZO® device
Timepoint [8] 403133 0
BIS measurements will be recorded pre-treatment, after 5, 10, 15, 20 and 25 fractions, weekly during radiation therapy treatment break, 1, 2 and 6 weeks post radiation therapy treatment, 3 and 6 months post radiation therapy treatment.

Eligibility
Key inclusion criteria
1. Be aged 50 years or older
2. Have symptomatic extensive skin field cancerisation (ESFC) greater than 50cm2
3. Be undergoing wide field (>50cm2), VMAT radiation therapy to the lower limb at
GenesisCare trial sites in NSW.
4. Understand and have provide written informed consent for participation in this trial.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have received prior VMAT wide field radiotherapy (>50cm2 ) to either leg.
2. History of lymphoedema in either lower limb
3. Lower limb peripheral vascular intervention prior to radiation therapy
4. Cardiac pacemaker or Implantable Cardioverter Defibrillator (ICD)
5. Allergy to shellfish or iodine
6. Any other condition/factor as defined by the investigator which significantly impact the
patient’s involvement and suitability in this study

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Pilot studies are designed to provide preliminary evidence on the feasibility (rather than statistical significance) of methods and procedures which can then be followed up with larger trials. There is little published guidance on sample size required for pilot studies. For this study a sample size of 10 has been decided to allow accuracy while taking into consideration budget, participant recruitment and time constraints.
The sampled patient population will be characterised by the summary demographic data.
The primary endpoint of weekly limb volume changes will be analysed with several methods. Graph the observed mean, and 95% CI over time, box plots of limb volume at key time points, scatterplots of limb volume and linear or curvi-linear regression of volume change.
MDACC lymphoedema staging will be formed into 2 categories to facilitate tabulation and logistic regression,
Volume assessments and the relationship between percent limb volume change and L-Dex score will be analysed with scatterplots, fit linear or curvi-linear regression as appropriate. In addition volume assessments further analysed to look at the differences between the means using analysis of variance (ANOVA).
PRO’s will be analysed over time with a mixed model for repeated measurements (MMRM).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/03/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
10
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20476 0
GenesisCare - Macquarie University Hospital - Macquarie University
Recruitment hospital [2] 20477 0
GenesisCare - Mater Hospital - North Sydney
Recruitment hospital [3] 20478 0
GenesisCare - Concord - Concord West
Recruitment postcode(s) [1] 35246 0
2060 - North Sydney
Recruitment postcode(s) [2] 35245 0
2109 - Macquarie University
Recruitment postcode(s) [3] 35247 0
2138 - Concord West

Funding & Sponsors
Funding source category [1] 309603 0
Commercial sector/Industry
Name [1] 309603 0
Cancer Care Research Pty Limited
Country [1] 309603 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cancer Care Research Pty Limited
Address
Building 1&11,
The Mill, 41-43 Bourke Road,
Alexandria NSW 2015
Australia
Country
Australia
Secondary sponsor category [1] 310617 0
None
Name [1] 310617 0
Address [1] 310617 0
Country [1] 310617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309378 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 309378 0
Research Services
Ground Floor, 16 Wally's Walk
Macquarie University,
NSW 2109, Australia
Ethics committee country [1] 309378 0
Australia
Date submitted for ethics approval [1] 309378 0
16/11/2020
Approval date [1] 309378 0
12/02/2021
Ethics approval number [1] 309378 0
9365

Summary
Brief summary
With recent advances in radiation therapy, non-melanoma skin cancer of the legs may be treated using volumetric modulated arc therapy (VMAT). The purpose of this study is to monitor swelling during and following VMAT treatment.
Who is it for?
You may be eligible for this study if you are aged 50 years or above, have symptomatic extensive skin field cancerisation, and are undergoing VMAT radiation therapy.
Study details
All participants in this study will continue to receive VMAT radiation therapy as per routine clinical care. Participants will undergo two indocyanine green lymphography scans which will be used to map the lymphatics. These scans will be done prior to commencing radiation therapy and six months after completing radiation therapy. Additionally participants will have their legs measured (using a tape measure), bioimpedance spectroscopy (BIS) measurements using the SOZO® ImpediMed, Australia) device, and fill in questionnaire/s weekly during their radiation therapy then at 1,2 and 6 weeks, and 3- and 6-months post completion of radiation therapy. BIS a non-invasive, pain free method of measuring fluid levels and body composition. All additional study assessments except for the ICG lymphography scans will be completed when the participant attends for clinical review.
It is hoped that this research will reveal factors that influence swelling during VMAT treatment and improve understanding of radiation therapy for treating non-melanoma skin cancer.
Trial website
www.genesiscare.com/au/clinical-trial/evolve
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113946 0
Dr Chelsie O'Connor
Address 113946 0
GenesisCare,
Macquarie University Hospital
Suite 1, Level B2, 3 Technology Place
Macquarie University NSW 2109
Country 113946 0
Australia
Phone 113946 0
+61 02 98123220
Fax 113946 0
Email 113946 0
chelsie.oconnor@genesiscare.com
Contact person for public queries
Name 113947 0
Ms Lori Lewis
Address 113947 0
GenesisCare,
Macquarie University Hospital
Suite 1, Level B2, 3 Technology Place
Macquarie University NSW 2109
Country 113947 0
Australia
Phone 113947 0
+61 02 9850 2347
Fax 113947 0
Email 113947 0
lori.lewis@genesiscare.com
Contact person for scientific queries
Name 113948 0
Dr Chelsie O'Connor
Address 113948 0
GenesisCare,
Macquarie University Hospital
Suite 1, Level B2, 3 Technology Place
Macquarie University NSW 2109
Country 113948 0
Australia
Phone 113948 0
+61 02 98123220
Fax 113948 0
Email 113948 0
chelsie.oconnor@genesiscare.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.