Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000333314
Ethics application status
Approved
Date submitted
16/01/2017
Date registered
3/03/2017
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comprehensive endoscopic lung cancer staging to optimize radiation planning in patients with locally advanced non-small cell lung cancer
Scientific title
Systematic EndoscopIc Staging of the Mediastinum to determine Impact on radiotherapy for locally advanced lung Cancer
Secondary ID [1] 290925 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SEISMIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 301648 0
stage III NSCLC 301649 0
Condition category
Condition code
Cancer 301359 301359 0 0
Lung - Non small cell
Respiratory 301360 301360 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure: systematic staging of mediastinal lymph nodes via endoscopic staging.
Staging will be performed by experienced respiratory physicians using a linear endobrnchial ultrasound videobronchoscope.
Patients will undergo standard FDG-PET prior to staging procedure. Staging procedure will be approximately 20-30 minutes duration, and be completed prior to radiation planning.

The staging procedure is an endoscopic procedure performed under deep sedation. Linear Endobronchial Ultrasound will be used to visualize all mediastinal LN stations (2R, 4R, 7, 4L, 2L) and to allow EBUS-TBNA sampling of any LN exceeding 6mm in short axis dimension)

Results from the staging procedure will be made available to Radiation Oncology team to allow optimal treatment planning

The treatment plan used in clinical care of patients will incorporate both PET and EBUS findings.
Theoretical planning will be performed to determine dosimetry in the event that only PET findings were available, to allow some estimation of the dosimetric impact (both dose to tumour, and toxicity risks) that detection of PET-occult disease by EBUS will have on patient outcomes
Intervention code [1] 296866 0
Diagnosis / Prognosis
Comparator / control treatment
Disease extent as determined by non-invasive FDG-PET
Control group
Active

Outcomes
Primary outcome [1] 300753 0
proportion of patients with Stage III NSCLC in whom systematic endoscopic mediastinal staging detects PET-occult lymph node NSCLC metastases
Timepoint [1] 300753 0
Endoscopic staging procedure
Secondary outcome [1] 330794 0
Proportion of patients with endoscopy-demonstrated benign lymph nodes at sites of FDG-avidity on PET/CT
Timepoint [1] 330794 0
Endoscopic staging procedure
Secondary outcome [2] 330795 0
Dosimetry impact of endoscopic staging (in patients where PET and Endoscopy demonstrate discordant staging outcomes). Dosimetry will be based on Radiation treatment plans established for PET versus Endoscopy-based Stage (only one plan will be delivered to patients)
Timepoint [2] 330795 0
Following endoscopic staging procedure
Secondary outcome [3] 330796 0
Impact of T-stage on likelihood of discrepant staging findings
Timepoint [3] 330796 0
Endoscopic staging procedure
Secondary outcome [4] 332260 0
Procedure duration (measured in minutes, recorded by investigators with stopwatch
Timepoint [4] 332260 0
at time of endoscopic staging procedure
Secondary outcome [5] 332298 0
Procedural complications (pneumothorax, infection, bleeding). All such complications will be determined through post-procedure clinical observation prior to discharge from hospital
Timepoint [5] 332298 0
at time of endoscopic staging procedure

Eligibility
Key inclusion criteria
Patients with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases. (stage III A-B based on mediastinal nodal involvement)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. medical co-morbidities preclude bronchoscopy
ii. medical co-morbidities or known pathologic extent of disease precludes consideration of radiotherapy
iii. age <18 or >80 years

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Diagnostic outcomes will be reported using the standard summary statistics, including sensitivity\specificity\Positive Predictive Value/ Negative Predictive Value

For comparison between groups, Categorical data will be examined using Fishers exact test, and continuous data will be examined using a parametric unpaired t-test

Logistic regression will be used to identify clinico-radiologiuc factors predictive for discrepant findings between EBUS & PET

Survival analysis will be conducted using the Kaplan-Meier method

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/03/2017
Actual
12/07/2017
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
198
Accrual to date
104
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 7317 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 7318 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 7319 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 7586 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 7587 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15092 0
3050 - Parkville
Recruitment postcode(s) [2] 15093 0
3168 - Clayton
Recruitment postcode(s) [3] 15094 0
3000 - Melbourne
Recruitment postcode(s) [4] 15481 0
5000 - Adelaide
Recruitment postcode(s) [5] 15482 0
4029 - Herston
Recruitment outside Australia
Country [1] 8574 0
Netherlands
State/province [1] 8574 0
Country [2] 8575 0
United States of America
State/province [2] 8575 0
Texas
Country [3] 22351 0
Canada
State/province [3] 22351 0
Ontario

Funding & Sponsors
Funding source category [1] 295344 0
Self funded/Unfunded
Name [1] 295344 0
Unfunded
Country [1] 295344 0
Primary sponsor type
Individual
Name
Daniel Steinfort
Address
C/- Dept Respiratory Medicine, Royal Melbourne Hospital
Level 1, Centre for Medical Research
Grattan St, Parkville 3050
Victoria
Country
Australia
Secondary sponsor category [1] 294169 0
None
Name [1] 294169 0
Address [1] 294169 0
Country [1] 294169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296678 0
Melbourne Health
Ethics committee address [1] 296678 0
Office for Research
Level 2, South West Wing
Royal Melbourne Hospital
300 Grattan Street
Parkville 3050
Victoria
Ethics committee country [1] 296678 0
Australia
Date submitted for ethics approval [1] 296678 0
27/07/2016
Approval date [1] 296678 0
13/10/2016
Ethics approval number [1] 296678 0
HREC/16/MH/227

Summary
Brief summary
The primary purpose of this trial is to evaluate whether endoscopic examination of the chest is useful for identifying disease sites in non-small cell lung cancer, which are not visible on standard care PET scans.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 to 80 years, with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases (stage III A-B based on mediastinal nodal involvement).

Study details
All participants enrolled in this trial will receive the endoscopic staging procedure in addition to the standard care PET scan. The endoscopic staging procedure will involve an endoscopy procedure (performed under deep intravenous sedation) where examination of all lymph nodes in the mediastinum will be performed, and sampling of any identified nodes perfomred. The procedure is required on the basis of your PET findings. The procedure lasts 20-30 minutes and is usually performed as a day procedure. The results of the staging procedure will be used to guide planning the dose of radiotherapy received. Researchers will compare the results obtained from the endoscopic staging procedure with the results from the PET scan to evaluate whether the staging procedure may be able to detect additional cancer sites which are not detected on the PET scan.

If so, this will improve targeting of radiation treatment in non-small cell lung cancer patients with mediastinal metastases by ensuring that all disease sites receive adequate radiation doses, thereby minimizing the risk of under-treatment and disease recurrence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71746 0
A/Prof Daniel Steinfort
Address 71746 0
C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkville, Victoria
Country 71746 0
Australia
Phone 71746 0
+61 3 9342 7708
Fax 71746 0
+61 3 8610 1687
Email 71746 0
[email protected]
Contact person for public queries
Name 71747 0
Ms Casey McLeod
Address 71747 0
C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkvi
Country 71747 0
Australia
Phone 71747 0
+61 3 9342 7708
Fax 71747 0
Email 71747 0
[email protected]
Contact person for scientific queries
Name 71748 0
A/Prof Daniel Steinfort
Address 71748 0
C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkville, Victoria
Country 71748 0
Australia
Phone 71748 0
+61 3 9342 7708
Fax 71748 0
Email 71748 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6889Study protocol    protocol to be published - manuscript in preparati... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSystematic endoscopic staging of mediastinum to determine impact on radiotherapy for locally advanced lung cancer (SEISMIC): protocol for a prospective single arm multicentre interventional study.2022https://dx.doi.org/10.1186/s12890-022-02159-9
N.B. These documents automatically identified may not have been verified by the study sponsor.