ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

SEISMIC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

lung cancer

stage III NSCLC

Condition category

Condition code

Cancer

Lung - Non small cell

Respiratory

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]

Diagnosis / Prognosis

Comparator / control treatment

Disease extent as determined by non-invasive FDG-PET

Control group

Active

Outcomes

Primary outcome [1]

proportion of patients with Stage III NSCLC in whom systematic endoscopic mediastinal staging detects PET-occult lymph node NSCLC metastases

Timepoint [1]

Endoscopic staging procedure

Secondary outcome [1]

Proportion of patients with endoscopy-demonstrated benign lymph nodes at sites of FDG-avidity on PET/CT

Timepoint [1]

Endoscopic staging procedure

Secondary outcome [2]

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]

Following endoscopic staging procedure

Secondary outcome [3]

Impact of T-stage on likelihood of discrepant staging findings

Timepoint [3]

Endoscopic staging procedure

Secondary outcome [4]

Procedure duration (measured in minutes, recorded by investigators with stopwatch

Timepoint [4]

at time of endoscopic staging procedure

Secondary outcome [5]

Procedural complications (pneumothorax, infection, bleeding). All such complications will be determined through post-procedure clinical observation prior to discharge from hospital

Timepoint [5]

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?

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]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [4]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [5]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

3050 - Parkville

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3000 - Melbourne

Recruitment postcode(s) [4]

5000 - Adelaide

Recruitment postcode(s) [5]

4029 - Herston

Recruitment outside Australia

Country [1]

Netherlands

State/province [1]

Country [2]

United States of America

State/province [2]

Texas

Country [3]

Canada

State/province [3]

Ontario

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

Office for Research
Level 2, South West Wing
Royal Melbourne Hospital
300 Grattan Street
Parkville 3050
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2016

Approval date [1]

13/10/2016

Ethics approval number [1]

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

A/Prof Daniel Steinfort

Address

C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkville, Victoria

Country

Australia

Phone

+61 3 9342 7708

Fax

+61 3 8610 1687

daniel.steinfort@mh.org.au

Contact person for public queries

Name

Casey McLeod

Address

C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkvi

Country

Australia

Phone

+61 3 9342 7708

Fax

casey.mcleod@mh.org.au

Contact person for scientific queries

Name

Daniel Steinfort

Address

C/- Dept Respiratory Medicine
Level 1, Centre for Medical Research
Royal Melbourne Hospital
Grattan St
RMH 3050
Parkville, Victoria

Country

Australia

Phone

+61 3 9342 7708

Fax

daniel.steinfort@mh.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6889	Study 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

Source	Title	Year of Publication	DOI
Embase	Systematic endoscopic staging of mediastinum to determine impact on radiotherapy for locally advanced lung cancer (SEISMIC): protocol for a prospective single arm multicentre interventional study.	2022	https://dx.doi.org/10.1186/s12890-022-02159-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically