Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000320651
Ethics application status
Approved
Date submitted
22/02/2023
Date registered
25/03/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
25/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes in patients with early oesophageal cancer managed by non-surgical treatment.
Scientific title
Outcomes in patients with high risk intramucosal cancer and superficial submucosal oesophageal adenocarcinoma managed initially with endoscopic local resection – a multi-centre retrospective study
Secondary ID [1] 309058 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oesophageal cancer 329118 0
Condition category
Condition code
Cancer 326090 326090 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study in patients who have undergo endoscopic removal of early oesophageal cancers classified as high risk after removal.

As this is a retrospective review, there is no active participation and all data will be from medical records collected as part of routine clinical practice.

After endoscopic removal of a high risk early cancer, patients will be observed for any clinical, radiological or surgical evidence of recurrent/residual cancer. This information is routinely collected as part of routine clinical care and will simply be collated for analysis at the end of the study period.

This is a retrospective study and therefore participants will not be required to complete any questionnaires.

The intention is to observe outcomes more than 5 years after initial removal of the high risk cancer however all data will be collect regardless of follow-up interval.

All data will be retrospectively collected, however all centers have prospectively collected this data as part of routine clinical care in treatment databases.
Intervention code [1] 325500 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333955 0
1. To assess the rates of cancer recurrence both locally, nodally or metastatic as a composite primary outcome.

This data will be sourced through review of medical records, imaging (CT/PET), endoscopic and surgical findings.
Timepoint [1] 333955 0
It is aimed to collected a minimum of 5 years outcome data from the date of resection of the high risk cancer. In general patients are assessed 3 monthly for the first year, then 6 monthly and then annual to 5 years.
Secondary outcome [1] 418827 0
To determine patient survival and describe the cause(s) of death
Timepoint [1] 418827 0
5 years post resection of high risk cancer. Outcome will be determined at last follow-up as recorded in the patients medical records.
Secondary outcome [2] 418828 0
To describe surgical mortality in surgical candidates
Timepoint [2] 418828 0
30 days post surgery
Secondary outcome [3] 418829 0
To describe the use of adjuvant chemotherapy/radiotherapy post endoscope local resection (ELR) / surgery. This data will be sourced from medical records.
Timepoint [3] 418829 0
5 years post resection of high risk cancer. Outcome will be determined at last follow-up as recorded in the patients medical records.
Secondary outcome [4] 418830 0
To describe the method of ELR, including Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD). This data will be sourced for treatment databases and patient medical records.
Timepoint [4] 418830 0
5 years post resection of high risk cancer.
Secondary outcome [5] 418831 0
To determine cancer-free survival
Timepoint [5] 418831 0
5 years post resection of high risk cancer.
Secondary outcome [6] 419822 0
To describe surgical morbidity in surgical candidates
Timepoint [6] 419822 0
5 years post surgical management.

Eligibility
Key inclusion criteria
All patients greater than or equal to 18 years-old, with a diagnosis of high risk T1a (HR-IMC) and T1b Oesophageal Adenocarcinoma (OAC) on ELR specimens.

(T1a and T1b is not an acronym but rather a T stage so this can't be written out)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age < 18 years;
• Prior surgery for oesophageal cancer
• Known Lymph node or distant metastasis seen on baseline staging EUS, CT or PET

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
A sample of 200 participants’ data (approximately 20 at each site) will be reviewed for this descriptive study.
Patients will be stratified according to histopathological grading (T1a/T1b disease or AJCC staging) and treatment (ELR vs surgical) status. Descriptive summaries of patient cohort demographic and clinical data will consist of frequency distributions (n, %) for categorical data and means and standard deviations or medians and interquartile ranges for continuous data, depending on data distribution. Incidences of cancer recurrence (local, nodal or metastatic) and mortality outcomes (overall and disease-free survival) over the study period will be described using frequency distributions. Time to event survival outcomes (recurrence and mortality) will be examined using Kaplan-Meier survival probabilities and summarised using medians and 95% confidence intervals (CIs).
Stata version 17.0 (StataCorp, College Station, TX) will be used for data analysis and significance (alpha) will be set at 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
30/10/2023
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
82
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 24089 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 24090 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 24091 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 24092 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment hospital [5] 24093 0
The Wesley Hospital - Auchenflower
Recruitment hospital [6] 24094 0
Western Hospital - Footscray - Footscray
Recruitment hospital [7] 24095 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 24096 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 24097 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 24098 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 24099 0
Melbourne Endoscopy Monash Day Procedure Centre - Clayton
Recruitment postcode(s) [1] 39597 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 39598 0
4029 - Herston
Recruitment postcode(s) [3] 39599 0
5000 - Adelaide
Recruitment postcode(s) [4] 39600 0
4169 - Kangaroo Point
Recruitment postcode(s) [5] 39601 0
4066 - Auchenflower
Recruitment postcode(s) [6] 39602 0
3011 - Footscray
Recruitment postcode(s) [7] 39603 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 39604 0
6000 - Perth
Recruitment postcode(s) [9] 39605 0
6150 - Murdoch
Recruitment postcode(s) [10] 39606 0
6009 - Nedlands
Recruitment postcode(s) [11] 39607 0
3168 - Clayton
Recruitment outside Australia
Country [1] 25281 0
New Zealand
State/province [1] 25281 0
Middlemore

Funding & Sponsors
Funding source category [1] 313262 0
Government body
Name [1] 313262 0
WA Cancer Network
Country [1] 313262 0
Australia
Funding source category [2] 313263 0
Commercial sector/Industry
Name [2] 313263 0
Olympus Medical
Country [2] 313263 0
Australia
Primary sponsor type
Government body
Name
WA Cancer Network
Address
North Metro Health Service, Verdun Street, NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 314996 0
Commercial sector/Industry
Name [1] 314996 0
Olympus Medical
Address [1] 314996 0
3 Acacia Place, Notting Hill, Victoria 3168, Australia
Country [1] 314996 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312493 0
Sir Charles Gairdner Osborne Park Health Care Group (SCGOPHCG) - Scientific Review Subcommittee
Ethics committee address [1] 312493 0
2nd Floor A Block
Hospital Avenue
NEDLANDS Western Australia 6009
Ethics committee country [1] 312493 0
Australia
Date submitted for ethics approval [1] 312493 0
12/11/2022
Approval date [1] 312493 0
05/12/2022
Ethics approval number [1] 312493 0
RGS0000005710

Summary
Brief summary
Contemporary treatment of early oesophageal (food pipe) cancer, involves minimally invasive endoscopic procedures; while surgery is reserved only for cases with the highest-risk of the cancer spreading into the surrounding tissues.
The risk of cancer spread is determined by samples removed at endoscopy, in which a pathologist is looking to see the depth of cancer spread into the wall of the oesophagus or for abnormal characteristics of the cancer.
The purpose of this study is to try and identify patients who are considered higher risk by conventional practice, who are actually at low risk for cancer spread; and, thus can forgo the need for a major operation with poor post-operative outcomes with respect to quality of life, morbidity and mortality.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a high risk oesophageal cancer removed at endoscopy.

Study details
This observational study will be reviewing the medical records of patients who meet the inclusion criteria only. Participants who meet the inclusion criteria will not be required to attend any additional clinic visits or complete assessments; all relevant information will be extracted from medical records directly.

It is hoped this research will determine which patients, with lower risk of cancer spread would be considered candidates for non-surgical management, to avoid an unnecessary (major) oesophageal operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124858 0
A/Prof Spiro Raftopoulos
Address 124858 0
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Country 124858 0
Australia
Phone 124858 0
+61 8 64570112
Fax 124858 0
Email 124858 0
[email protected]
Contact person for public queries
Name 124859 0
Spiro Raftopoulos
Address 124859 0
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Country 124859 0
Australia
Phone 124859 0
+61 8 64570112
Fax 124859 0
Email 124859 0
[email protected]
Contact person for scientific queries
Name 124860 0
Spiro Raftopoulos
Address 124860 0
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Country 124860 0
Australia
Phone 124860 0
+61 8 64570112
Fax 124860 0
Email 124860 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
18405Study protocol    385450-(Uploaded-22-02-2023-00-18-55)-Study-related document.pdf
18407Ethical approval    385450-(Uploaded-22-02-2023-00-19-40)-Study-related document.pdf



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.