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Trial registered on ANZCTR


Registration number
ACTRN12620001264976
Ethics application status
Approved
Date submitted
27/08/2020
Date registered
25/11/2020
Date last updated
14/07/2022
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel Delivery of Chemotherapy for Treatment of Patients with Mesothelioma: A Feasibility Study
Scientific title
Transarterial Chemoperfusion Treatment in Patients with Unresectable Pleural Mesothelioma: A Feasibility Study
Secondary ID [1] 302149 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant pleural mesothelioma 318790 0
Condition category
Condition code
Cancer 316804 316804 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo an angiogram and transarterial chemoperfusion procedure approximately 60 minutes in length, which involves injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. The chemotherapy agents will be administered into the thoracic aorta and/or the intercostal arteries and/or the internal mammary artery on the side of the disease. The chemotherapy agents and dosage utilised will include the following; cisplatin (35 mg/m^2 body surface area (BSA)), methotrexate (100 mg/m^2 BSA) and gemcitabine (1000 mg/m^2 BSA). All agents used and dosage will remain the same for all patients with modification at the discretion of the MDT meeting members (treating physicians).
Patients will attend Wesley Medical Imaging for repeat chemoperfusion treatment every 4 weeks (3-6 week interval allowed), if clinically appropriate, until disease progression is confirmed AND there is no evidence of a treatment response on follow-up CT scans.
Follow-up CT scan will be performed every 12 weeks, or earlier if deemed clinically necessary, to monitor response to treatment. As per the international guidelines response to treatment will be de?ned as per the Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma.
Intervention code [1] 318447 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324921 0
Safety of intra-arterial chemoperfusion for MPM, as measured by occurrence of adverse events.
Safety will be assessed by monitoring adverse events as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.
Possible adverse effects include: Off-target spread of the chemotherapy agents; non-target embolisation, infection, pain, bruising or bleeding at the puncture site, failure to respond to treatment, damage to the blood vessels, toxicity from chemotherapy agent/s.
Timepoint [1] 324921 0
Safety will be assessed 1 week post procedure after each treatment cycle until disease progression is confirmed and patient does not proceed with further treatment cycles.
Grading of the toxicity and adverse events will be done as per Common Terminology Criteria for adverse events (CTCAE) v5.
Primary outcome [2] 324922 0
Efficacy of intra-arterial chemoperfusion for MPM, as measured by disease response, according to the RECIST criteria for mesothelioma.
Timepoint [2] 324922 0
Follow-up CT scan will be performed every 12 weeks, or earlier if deemed clinically necessary, to monitor response to treatment and assessed by RECIST. This will occur after each treatment cycle until disease progression is confirmed and patient does not proceed with further treatment cycles.
Secondary outcome [1] 386210 0
Quality of life as measured by Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Timepoint [1] 386210 0
Questionnaire will be administered at baseline, and at week 4 and week 8 after each treatment cycle until disease progression is confirmed and patient does not proceed with further treatment cycles.
Secondary outcome [2] 388032 0
Symptoms as measured by Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Timepoint [2] 388032 0
Questionnaire will be administered at baseline, and at week 4 and week 8 after each treatment cycle until disease progression is confirmed and patient does not proceed with further treatment cycles.
Secondary outcome [3] 388033 0
Overall survival of intra-arterial chemoperfusion for MPM as assessed by date of death.
Timepoint [3] 388033 0
Date of death.
Secondary outcome [4] 388034 0
Progression free survival of intra-arterial chemoperfusion for MPM as assessed by disease response on CT scan and according to the RECIST criteria for mesothelioma.
Timepoint [4] 388034 0
Follow-up CT scan will be performed every 12 weeks, or earlier if deemed clinically necessary, to monitor response to treatment and assessed by RECIST. This will occur after each treatment cycle until disease progression is confirmed and patient does not proceed with further treatment cycles.

Eligibility
Key inclusion criteria
• Histologically or cytologically confirmed MPM.
• Tumour/s assessed as inoperable or refuses surgery.
• The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
• Failure to respond to first line standard of care chemotherapy.
• Have measurable disease, by computed tomography (CT) as per modified Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma.
• Ability to understand and the willingness to sign a written informed consent document.
• Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.
• An ECOG performance status score <3.
• Patient is expected to survive and be available for follow up for at least 12 months.
• Patients must have private health insurance to be included in this trial and eligible for treatment at The Wesley Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Large pulmonary-systemic shunting of tumour vasculature, as demonstrated on preliminary angiogram.
• Patients who have had chemotherapy within 4 weeks prior to entering the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study.
• History of moderate and severe allergic reaction to intravenous iodinated contrast media is not a contraindication to the study.
• Involvement in trials with other investigational agents.
• Patient with synchronous primary tumours requiring other therapy.
• Uncontrolled intercurrent illness including, but not limited to, renal dysfunction, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Women who are pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17344 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 31072 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 306576 0
Commercial sector/Industry
Name [1] 306576 0
I-MED Radiology Network
Country [1] 306576 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology
Address
I-MED Radiology
The Wesley Hospital
87 Lang Pde
Auchenflower QLD 4066
Country
Australia
Secondary sponsor category [1] 307109 0
None
Name [1] 307109 0
Address [1] 307109 0
Country [1] 307109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306760 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 306760 0
Ethics committee country [1] 306760 0
Australia
Date submitted for ethics approval [1] 306760 0
23/06/2020
Approval date [1] 306760 0
13/11/2020
Ethics approval number [1] 306760 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104926 0
Dr Nicholas Brown
Address 104926 0
I-MED Radiology
The Wesley Hospital
Level 2
30 Chasely St
Auchenflower QLD 4066
Country 104926 0
Australia
Phone 104926 0
+61 07 33719588
Fax 104926 0
Email 104926 0
[email protected]
Contact person for public queries
Name 104927 0
Sepinoud Firouzmand
Address 104927 0
I-MED Radiology
The Wesley Hospital
87 Lang Pde
Auchenflower QLD 4066
Country 104927 0
Australia
Phone 104927 0
+61 07 33719588
Fax 104927 0
Email 104927 0
[email protected]
Contact person for scientific queries
Name 104928 0
Sepinoud Firouzmand
Address 104928 0
I-MED Radiology
The Wesley Hospital
87 Lang Pde
Auchenflower QLD 4066
Country 104928 0
Australia
Phone 104928 0
+61 07 33719588
Fax 104928 0
Email 104928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be shared with the respective individuals in the study and publishing/sharing via conference presentations or journal articles is planned to share the cohort data publicly.


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.