Trial Review

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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
Sex
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
1/02/2011
Actual
10/02/2011
Date of last participant enrolment
Anticipated
31/12/2012
Actual
23/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
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)
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
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
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
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
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


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.