Outcomes in patients with early oesophageal cancer managed by non-surgical treatment.
Not Applicable
Recruiting
- Conditions
- oesophageal cancerCancer - Oesophageal (gullet)
- Registration Number
- ACTRN12623000320651
- Lead Sponsor
- WA Cancer Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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)
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the rates of cancer recurrence both locally, nodally or metastatic as a composite primary outcome.<br><br>This data will be sourced through review of medical records, imaging (CT/PET), endoscopic and surgical findings.[ 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 Measures
Name Time Method To determine patient survival and describe the cause(s) of death[ 5 years post resection of high risk cancer. Outcome will be determined at last follow-up as recorded in the patients medical records.];To describe surgical mortality in surgical candidates[ 30 days post surgery];To describe the use of adjuvant chemotherapy/radiotherapy post endoscope local resection (ELR) / surgery. This data will be sourced from medical records.<br>[ 5 years post resection of high risk cancer. Outcome will be determined at last follow-up as recorded in the patients medical records.];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.[ 5 years post resection of high risk cancer.];To determine cancer-free survival[ 5 years post resection of high risk cancer.];To describe surgical morbidity in surgical candidates[ 5 years post surgical management.]