The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000387729
Ethics application status
Approved
Date submitted
29/03/2013
Date registered
10/04/2013
Date last updated
10/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II Feasibility Study of Gold Fiducial Markers for
Surgical-Pathological Localisation and Chemotherapy Response
Assessment in the Multi-Disciplinary Team Management of
Oesophageal-Gastric Cancer
Scientific title
Adult patients with oesophageal-gastric cancer, to undergo an EUS guided fiducial insertion to mark the tumour in this phase II feasibility study for surgical pathological localisation and chemotherapy response assessment.
Secondary ID [1] 282193 0
No secondary ID
Universal Trial Number (UTN)
U1111-1141-1226
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal - gastric cancer 288702 0
Condition category
Condition code
Cancer 289050 289050 0 0
Oesophageal (gullet)
Cancer 289051 289051 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endoscopic ultrasound guided insertion of markers known as fiducials (inert gold markers) to delineate the tumour for the purpose of monitoring treatment response and anatomical localisation.
The markers are inserted into the superior/inferior margins of the tumour and if possible into the lateral margins. Therefore a total of between 2-4 tiny gold markers will be inserted. The duration of the enitre procedure including EUS staging is approximately 30 minutes.
Intervention code [1] 286797 0
Other interventions
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289163 0
Safety and feasibility of inserting EUS guided fiducials into oesophageal and gastric cancers.
Safety is assessed through immediate and delayed complications. The immediate complications relate to assessment of any complications at the time of the procedure (eg. bleeding, failure of insertion etc) and immediately post procedure in recovery (pain, bleeding etc). Delayed complications are assessed upto 30days post through routine reviews via outpatients clinic.
Feasibility is assessed through successful insertion rate classified endoscopically and or on radiological follow up.
Timepoint [1] 289163 0
Immediately post procedure and upto 30 days post procedure
Secondary outcome [1] 301951 0
Cancer response assessment utilizing fiducial markers at follow up imaging. This is assessed at the MDT comparing pre and post neoadjuvant imaging with fiducial marker placement to assess whether there is any reduction in size of the primary malignancy on CT imaging.
Timepoint [1] 301951 0
Following neoadjuvant chemo and or radiotherapy imaging.
Secondary outcome [2] 301952 0
Anatomical localization of the cancer in the surgical specimen
Timepoint [2] 301952 0
At the time of surgical excision of the primary malignancy.

Eligibility
Key inclusion criteria
Age>18yrs with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC)or adenocarcinoma of the stomach discussed at the upper gastro-intestinal multidisciplinary team meeting (MDT) were considered eligible if they fulfilled the inclusion criteria. These criteria included cancer stage (T1-3,N0-1,M0-1a), ECOG 0 or 1, medically suitable for oeosphagectomy and chemotherapy and or chemoradiotherapy, and written informed consent.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage M1b
Contraindications to CT contrast e.g. severe chronic kidney disease, allergy to contrast
Contraindications to PET/CT e.g. claustrophobia

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)
Patients fulfilling inclusion criteria who were discussed at the Austin Health upper GI MDT who were deemed appropriate for recruitment were consented through outpatients clinic prior to the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics.
The number of 20 patients was generated through review of previous MDTs over 12 months to assess number of possible participants that would be reviewed. This figure in addition to the expiry date of the fiducials was used to generate a figure of 20 which was felt to be a feasible number that could be recruited over this time point.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 810 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 6631 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 286964 0
Hospital
Name [1] 286964 0
Radiation oncology education fund (Austin Health)
Address [1] 286964 0
145 Studley Road
Department of Radiation Oncology.
Austin Health
Heidelberg
Victoria Australia 3084
Country [1] 286964 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Department of Radiation Oncology.
Austin Health
Heidelberg
Victoria Australia 3084
Country
Australia
Secondary sponsor category [1] 285755 0
None
Name [1] 285755 0
Address [1] 285755 0
Country [1] 285755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289021 0
Austin HREC
Ethics committee address [1] 289021 0
Austin Health
145 Studley Road
Heidelberg Vic 3084
Ethics committee country [1] 289021 0
Australia
Date submitted for ethics approval [1] 289021 0
14/09/2010
Approval date [1] 289021 0
15/12/2010
Ethics approval number [1] 289021 0
H2010/04062

Summary
Brief summary
This study is examining whether inserting gold markers (known as fiducial markers) into a tumour may aid surgical and chemotherapy response assessment in patients with oesophageal-gastric cancer.

Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC) or adenocarcinoma of the stomach.

Trial details: All participants in this trial will have 2-4 tiny gold markers (known as fiducial markers) inserted into the tissue beside their tumour during endoscopy. Endoscopy involves having a tube inserted into the back of the throat and takes about 30 minutes. Each gold marker is approximately the size of a grain of rice (1mm x 3mm). Having gold seed locators makes it easy for the surgeon or the radiotherapist to know exactly where to operate or irradiate because they show up clearly on the PET Scan, CAT Scan and Radiation Treatment machine. If the tumour shrinks very well with chemotherapy then the Pathologist may not know exactly where to find the tumour in the tissue removed. This can make it very difficult to provide a precise report and hence the need for any follow-up treatment after surgery. This study will not affect routine treatment in any other way. We wish to study approximately 20 patient’s scans and pathology reports to see exactly how much improvement we get in correlating these gold markers with scan results. At the moment there is no good information to show that they consistently improve accuracy of treatment for stomach and oesophageal tumours. We have good information over the last 40 years that gold marker seeds improve accuracy in Head and Neck Cancer and Cervical Cancer. Over the last 10 years they have become indispensable in Breast Cancer (titanium markers rather than gold) and particularly in prostate cancer radiotherapy, where gold seeds have reduced radiotherapy side effects massively in tens of thousands of men worldwide. Based on this information we expect that there will be benefits in the stomach and oesophagus as well.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38770 0
Prof Chris Hamilton
Address 38770 0
Department of Radiation Oncology
Austin Health
Olivia Newton John Building
145 Studley Road, Heidelberg Victoria 3084
Country 38770 0
Australia
Phone 38770 0
+61,03,94965000
Fax 38770 0
Email 38770 0
Chris.Hamilton@austin.org.au
Contact person for public queries
Name 38771 0
Prof Chris Hamilton
Address 38771 0
Department of Radiation Oncology
Austin Health
Olivia Newton John Building
145 Studley Road, Heidelberg Victoria 3084
Country 38771 0
Australia
Phone 38771 0
+61,03,94965000
Fax 38771 0
Email 38771 0
Chris.Hamilton@austin.org.au
Contact person for scientific queries
Name 38772 0
Prof Chris Hamilton
Address 38772 0
Department of Radiation Oncology
Austin Health
Olivia Newton John Building
145 Studley Road, Heidelberg Victoria 3084
Country 38772 0
Australia
Phone 38772 0
+61,03,94965000
Fax 38772 0
Email 38772 0
Chris.Hamilton@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary