Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000770561p
Ethics application status
Submitted, not yet approved
Date submitted
21/05/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Survival and Patterns of Care in the Era of Chemo-, Radio-, and Immuno-Oncology for Gastroesophageal Junction Cancers
Scientific title
Survival and Patterns of Care in the Era of Chemo-, Radio-, and Immuno-Oncology for Gastroesophageal Junction Cancers - A multicentre cohort study
Secondary ID [1] 312063 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPACE-CRIO
Linked study record
ACTRN12622000180718
SPACE-CRIO is a follow-up study comparing FLOT cohort from SPACE-FLOT to those with receiving chemoradiation and immunotherapy for gastroesophageal junction cancers.

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal adenocarcinomas 333673 0
Gastroesophageal cancer 333674 0
Gastric cancer 333675 0
Gastric adenocarcinomas 333676 0
Condition category
Condition code
Cancer 330361 330361 0 0
Stomach
Cancer 330362 330362 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
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).
Intervention code [1] 328507 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338132 0
Three-year disease-free survival. This will be assessed by accessing and analysing patient electronic medical records.
Timepoint [1] 338132 0
Three-year disease-free survival: Time from histological diagnosis until disease progression (identified clinically, biochemically, and/or radiologically) or death. The proportion of patients still disease-free and alive at three-years is defined as three-year DFS.
Secondary outcome [1] 434616 0
Five year disease free survival. This will be assessed by accessing and analysing patient electronic medical records.

Timepoint [1] 434616 0
Five-year disease-free survival: Time from histological diagnosis until disease progression (identified clinically, biochemically, and/or radiologically) or death. The proportion of patients still disease-free and alive at five-years is defined as five-year DFS.

Secondary outcome [2] 434617 0
Three-year overall survival. This will be assessed by accessing and analysing patient electronic medical records.
Timepoint [2] 434617 0
Three-year OS: Time from histological diagnosis until death. The proportion of patients alive at two-years is defined as hree-year OS.
Secondary outcome [3] 434618 0
Five-year overall survival. This will be assessed by accessing and analysing patient electronic medical records.
Timepoint [3] 434618 0
Time from histological diagnosis until death. The proportion of patients alive at five-years is defined as five-year OS.
Secondary outcome [4] 434619 0
Anatomical location of disease recurrence
Timepoint [4] 434619 0
Disease recurrence will be measured at 1 year post surgery, 3 years post surgery and 5 years post surgery
Secondary outcome [5] 434620 0
Rate of completion of adjuvant therapy
Timepoint [5] 434620 0
Adjuvant therapy completion will be reviewed at 1 year post surgery, 3 years post surgery and 5 years post surgery
Secondary outcome [6] 434621 0
Reasons for not completing adjuvant therapy
Timepoint [6] 434621 0
Adjuvant therapy compliance will be reviewed at 1 year post surgery, 3 years post surgery and 5 years post surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
9/02/2026
Actual
Date of last data collection
Anticipated
10/02/2031
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316422 0
Other
Name [1] 316422 0
Peter MacCallum Cancer Centre
Country [1] 316422 0
Australia
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 318592 0
None
Name [1] 318592 0
Address [1] 318592 0
Country [1] 318592 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315217 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315217 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 315217 0
Australia
Date submitted for ethics approval [1] 315217 0
13/05/2024
Approval date [1] 315217 0
Ethics approval number [1] 315217 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134014 0
Dr David Liu
Address 134014 0
Division of Cancer Surgery Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000
Country 134014 0
Australia
Phone 134014 0
+61 402 857 529
Fax 134014 0
Email 134014 0
david.liu@petermac.org
Contact person for public queries
Name 134015 0
David Liu
Address 134015 0
Division of Cancer Surgery Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000
Country 134015 0
Australia
Phone 134015 0
+61 402 857 529
Fax 134015 0
Email 134015 0
david.liu@petermac.org
Contact person for scientific queries
Name 134016 0
David Liu
Address 134016 0
Division of Cancer Surgery Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000
Country 134016 0
Australia
Phone 134016 0
+61 402 857 529
Fax 134016 0
Email 134016 0
david.liu@petermac.org

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?

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.