Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001663145
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
27/11/2019
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiofrequency ablation Of Lung cancer followed by EXcision – A Clinical Feasibility Treat-Wait and Resect Study (ROLEX)
Scientific title
Radiofrequency ablation Of Lung cancer followed by EXcision – A Clinical Feasibility Treat-Wait and Resect Study (ROLEX)
Secondary ID [1] 299880 0
None
Universal Trial Number (UTN)
Trial acronym
ROLEX Clinical Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancerous / Malignant Lung Lesions 315292 0
Condition category
Condition code
Respiratory 313595 313595 0 0
Other respiratory disorders / diseases
Cancer 313596 313596 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiofrequency Ablation delivered to target lung areas (Cancerous Lesions). Radiofrequency Ablation involves the delivery of a measured dose of radiofrequency energy to the area surrounding the cancerous lesion.
The radiofrequency ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital.
Dose(s) of up to 80 watts of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection. This procedure will generally take less than 60 minutes to perform.
Lung resection will then occur according to the standard hospital procedures.
Subjects will be treated with Radiofrequency ablation and the interval between ablation and resection will be a minimum of 48 hours to a maximum of 2 weeks, with the exact scheduling determined by the investigator.
Intervention code [1] 316145 0
Treatment: Devices
Comparator / control treatment
Nil comparator or control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322042 0
Safety will be evaluated as the 30-day (or date of Day 30 follow-up) number of reported adverse events (AEs), serious adverse events (SAEs) related to the radiofequency ablation procedure. Possible or known adverse events associated with the investigational device / procedure may include:
The possible risks associated with bronchoscopy::

- Very Common (>50%) - none.
- Common (between 10% and 50% - Sore throat, Injury to teeth, Bleeding.
- Uncommon (between 1% and 10%) - Asthma-like reaction, Fever. Rare (<1%) - Infection (higher risk for smokers), Thrombosis (blood clot) in legs, Pneumothorax, Myocardial infarction (heart attack), Pulmonary edema, Cardiac arrest, Spasm of the muscles in your airway and / or voice box, Death.

The possible risks of the Radiofrequency Ablation treatment:

- Very Common (>50%) - None.
- Common (between 10% and 50%) - Bronchitis or pneumonitis (airway inflammation), Cough, Minor bleeding, Pain at the treatment site, Respiratory distress.
- Uncommon (between 1% and 10%) - Fever, Fatigue, Loss of appetite, Pneumonia, Infection, Damage to lung lobes, chest wall or heart, Pleural effusion (fluid between chest wall and lungs), Pericardial effusion (fluid between the heart and the pericardium), Pneumothorax (collapsed lung), Haemoptysis (coughing up blood), Nausea and vomiting.
- Rare (<1%) - Haemothorax (blood between the chest wall and lungs), Cardiac arrhythmias, Myocardial infarction (heart attack), Oesophageal injury, Nerve injury , Brain damage, Death.
Timepoint [1] 322042 0
Up to and including 30 Days following surgical resection
Secondary outcome [1] 377139 0
Feasibility will be evaluated by assessing the ability of the Zidan Medical RFA System to achieve the following:

- Successful delivery of the radiofrequency ablation treatment according to the IFU and treatment plan.
- Histological evidence of ablation using a H&E tissue viability stain to assess the extent of the coagulative necrotic zone in relation to the tumor focus, as well as zones of temporary inflammation and edema.
- CT imaging, between ablation and resection procedures, to identify the extent of treatment areas.
Timepoint [1] 377139 0
During and at the completion of the BTVA-C Procedure

Eligibility
Key inclusion criteria
1. Age: greater than or equals to years old
2. Non-small cell lung cancer tumor(s) less than or equal to 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) less than or equal to 4cm suitable for resection
3. Suitable candidate for resection per standard of practice (lobectomy)
4. Microscopic proof of malignancy of lung cancer lesion to be ablated obtained.
5. Location of tumor:
a. In outer two thirds of lung (outermost 2/3 – located distal to 5th bronchial generation)
b. Anticipation that resection (lobectomy) would remove all gross tumor and ablation with grossly negative margins
c. One or more radiofrequency ablation applications would target entire margin according to the RFA plan
6. Signed informed consent as prescribed by hospital policies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The following lesions should be excluded from the study for safety reasons:
a. Centralized tumor (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea).
b. Tumors less than 1cm from any pleural surface
c. Tumours that do not have normal lung clearance of less than 1cm around the target lesion.
d. Tumours that are less than 2cm from major pulmonary artery vasculature (as assessed by CT)
2. Carcinoid lung tumors
3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
4. Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
5. Requirement for supplemental oxygen at rest or exercise
6. Hospitalization for cardiac disease within the preceding 6 months
7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
8. Serum creatinine greater than 2 mg/dl
9. Recent infection (within 30 days)
10. Receiving immunosuppressive medication or prednisone greater than 10 mg/day (or equivalent)
11. Pre-existing implants within the airways that impede navigation to the target lesion
12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
13. Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days, post-procedure.
14. Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives
15. Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives

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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Phase 1 safety and feasibility study not powered for a result

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
19/06/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15282 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 28592 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 304325 0
Commercial sector/Industry
Name [1] 304325 0
Zidan Medical Inc.
Country [1] 304325 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Zidan Medical Inc.
Address
2326 Walsh Avenue
Santa Clara, CA 95051
United States of America
Country
United States of America
Secondary sponsor category [1] 304571 0
None
Name [1] 304571 0
Address [1] 304571 0
Country [1] 304571 0
Other collaborator category [1] 281055 0
Commercial sector/Industry
Name [1] 281055 0
Australian Healthcare Solutions
Address [1] 281055 0
Level 1 / 424 Burke Road
Camberwell, Victoria, Australia 3124
Country [1] 281055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304774 0
Melbourne Health
Ethics committee address [1] 304774 0
Ethics committee country [1] 304774 0
Australia
Date submitted for ethics approval [1] 304774 0
25/09/2019
Approval date [1] 304774 0
28/10/2019
Ethics approval number [1] 304774 0
HREC/57582/MH-2019

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

Contacts
Principal investigator
Name 98162 0
A/Prof Daniel Steinfort
Address 98162 0
The Royal Melbourne Hospital
Dept Respiratory Medicine
Grattan Street
PARKVILLE VIC 3050
Country 98162 0
Australia
Phone 98162 0
+61 03 9342 7708
Fax 98162 0
Email 98162 0
[email protected]
Contact person for public queries
Name 98163 0
Matt Godden
Address 98163 0
Australian Healthcare Solutions
Level 1 / 424 Burke Road
Camberwell, Victoria, 3124
Country 98163 0
Australia
Phone 98163 0
+61400007127
Fax 98163 0
Email 98163 0
[email protected]
Contact person for scientific queries
Name 98164 0
Daniel Steinfort
Address 98164 0
The Royal Melbourne Hospital
Dept Respiratory Medicine
Grattan Street
PARKVILLE VIC 3050
Country 98164 0
Australia
Phone 98164 0
+61 03 9342 7708
Fax 98164 0
Email 98164 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
Individual data not available


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
SourceTitleYear of PublicationDOI
EmbaseBronchoscopic treatments for early-stage peripheral lung cancer: Are we ready for prime time?.2020https://dx.doi.org/10.1111/resp.13903
EmbaseTherapeutic Bronchoscopy for Lung Nodules: Where Are We Now?.2022https://dx.doi.org/10.1055/s-0042-1749368
N.B. These documents automatically identified may not have been verified by the study sponsor.