None listed
Conditions
Brief summary
This study aims to address the lack of information on the efficacy and safety of surgery in combination with chemotherapy (FLOT) alone OR chemotherapy, radiotherapy and immunotherapy (CROSS/nivolumab) in treating cancers involving the lower oesophagus and the junction of the oesophagus and stomach (GOJ cancers). This lack of information may lead to significant variations in practice as clinicians lack the evidence to help decide which treatment is best for their patients. This has led to unnecessary harm and even deaths due to potentially avoidable treatment complications and early cancer recurrence. Who is it for? You may be eligible for this study if you are aged 18 years and over, with adenocarcinoma involving the lower oesophagus and GOJ who underwent surgical resection. Received either neoadjuvant CROSS chemoradiation + adjuvant nivolumab OR perioperative FLOT chemotherapy between 1st January 2017 to 31st December 2023. Study details For all participants, information regarding survival and disease progression (identified clinically, biochemically, and/or radiologically) will be obtained from your electronic medical record, with no study visits or additional testing required. This data will be used to compare the survival and disease progression between different treatments. It is hoped that this research will determine how immune cells within these cancers respond to the different treatments, which will serve to inform clinicians of the optimal, personalised treatment for their patient that derives maximal benefit whilst reducing harm.
Interventions
Cancers involving the lower oesophagus and the junction of the oesophagus and stomach (GOJ cancers) are treated with surgery in combination with chemotherapy (FLOT) alone OR chemotherapy, radiotherapy and immunotherapy (CROSS/nivolumab). However,information comparing the efficacy and safety of the two approaches is lacking.
This multicentre retrospective clinical data and archival tissue biomarker study will collect data about patients who have received either neoadjuvant CROSS chemoradiation +
Cancers involving the lower oesophagus and the junction of the oesophagus and stomach (GOJ cancers) are treated with surgery in combination with chemotherapy (FLOT) alone OR chemotherapy, radiotherapy and immunotherapy (CROSS/nivolumab). However,information comparing the efficacy and safety of the two approaches is lacking. This multicentre retrospective clinical data and archival tissue biomarker study will collect data about patients who have received either neoadjuvant CROSS chemoradiation + adjuvant nivolumab or perioperative FLOT chemotherapy and underwent surgery between 1st January 2017 to 31st December 2023 from 28 sites across Australia. Follow-up data collection is 5 years after the data of last patient (Dec 2028) for survival follow up information. Patient data will include: • Patient demographics, co-morbidities and characteristics • Treatment history including pre-operative, operative, and post-operative interventions • Post-operative complications within 30 days post-surgery • Clinicopathological and molecular features of disease • Disease outcomes and survival • Follow-up data until 2 years post-surgery All data collected from medical records (no active participant involvement).
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Any patient with adenocarcinoma involving the lower oesophagus and GOJ who underwent surgical resection. - Received either neoadjuvant CROSS chemoradiation + adjuvant nivolumab OR perioperative FLOT chemotherapy. - Age greater than 18 years-of-age.
Exclusion criteria
• Did not receive adjuvant nivolumab in those undergoing CROSS chemoradiation. • Did not receive FLOT in those undergoing perioperative chemotherapy. • Did not undergo radical surgical resection of the primary tumour. • Stage-4 disease at diagnosis.
Outcome results
None listed