Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000180718
Ethics application status
Approved
Date submitted
14/12/2021
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Survival and Patterns of Care in the Era of Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel (FLOT)-based Chemotherapy for Gastric and Gastroesophageal Adenocarcinoma (SPACE-FLOT):
An international multicentre cohort study
Scientific title
Survival and Patterns of Care in the Era of FLOT-based Chemotherapy for Gastric and Gastroesophageal Adenocarcinoma (SPACE-FLOT):
An international multicentre cohort study
Secondary ID [1] 306240 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPACE-FLOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal adenocarcinomas 324686 0
Gastroesophageal cancer 324687 0
Gastric cancer 324688 0
Gastric adenocarcinomas 324969 0
Condition category
Condition code
Cancer 322132 322132 0 0
Stomach
Cancer 322133 322133 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
To audit the patterns of care and survival outcomes of patients with gastric and gastroesophageal adenocarcinoma who have undergone preoperative FLOT-based chemotherapy and radical surgical resection stratified by pathological response in the resected specimen.

This study is an international (Australia, New Zealand, Singapore, Malaysia, Hong Kong, Vietnam, India, England, Ireland, Sweden, The Netherlands, France, and Canada) retrospective analysis of practice and outcomes between January 1 2017 to Dec 31 2022. Follow-up data collection is out to Dec 31, 2022 as we need a minimum one-year survival data. We aim to collect data for at least 1500 consecutive patients from all participating sites.

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] 322444 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329896 0
Two-year disease-free survival. This will be assessed by accessing and analysing patient electronic medical records.

Disease free survival: Time from histological diagnosis until disease progression (identified clinically, biochemically, and/or radiologically) or death
Timepoint [1] 329896 0
Two-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 two-years is defined as two-year DFS.
Secondary outcome [1] 404197 0
Two-year overall survival (OS):

Data will be collected through data-linkage to medical records. There will be no active participant involvement

Timepoint [1] 404197 0
Two-year OS: Time from histological diagnosis until death. The proportion of patients alive at two-years is defined as two-year OS.
Secondary outcome [2] 405348 0
One-year disease-free survival (DFS)

Data will be collected through data-linkage to medical records. There will be no active participant involvement
Timepoint [2] 405348 0
One-year DFS: 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 one-years is defined as one-year DFS.

Eligibility
Key inclusion criteria
• Any patient with gastric and gastroesophageal cancer
• Received preoperative FLOT-based chemotherapy and surgical resection between 01/01/2017 to 31/12/2021
• Age less than or equal to 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
• Received further neoadjuvant therapy in addition to FLOT chemotherapy
• Stage 4 disease at diagnosis
• Death within 30 days post resection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Univariate, multivariate, Kaplan Meier and cox regression analysis will be used in this study. This study is powered to address the 5th hypothesis. Based on the FLOT4 trial, 40% of patients did not receive adjuvant FLOT and the two-year DFS was 55%. Adjuvant chemotherapy is estimated to confer a DFS benefit of 15% at two years (i.e., two-year DFS of 40%, based on the adjuvant chemotherapy with surgery versus surgery alone studies in gastric and gastroesophageal cancers).5, 32 This equates to a hazard ratio of approximately 0.73. Based on this, we will deem 15% as a clinically significant difference in DFS. Therefore, to detect a DFS difference of 15% with 80% power at an alpha level of 0.05, assuming an enrolment ratio of 1 to 0.3 (using a conservative real-world estimate of 30% of patients not receiving adjuvant FLOT), the predicted sample size will be FLOT/surgery/FLOT group: 473 patients, and FLOT/surgery/no adjuvant FLOT group: 157 patients. In total, the number of patents required with minimal/no Tumour Regression Grade (TRG) in the resection specimen = 473 + 157 = 630. Based on local data, 40% of all resected gastric and gastroesophageal cancer show minimal/no TRG, the overall total number of patients required for this study: 630/0.4 = 1575 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/09/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
1575
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21320 0
The Canberra Hospital - Garran
Recruitment hospital [2] 21321 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 21322 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 21323 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 21324 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 21325 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 21326 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [8] 21327 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 21328 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [10] 21329 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [11] 21330 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 21331 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [13] 21332 0
The Northern Hospital - Epping
Recruitment hospital [14] 21333 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [15] 21334 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [16] 21335 0
Western Hospital - Footscray - Footscray
Recruitment hospital [17] 21336 0
Royal Hobart Hospital - Hobart
Recruitment hospital [18] 21337 0
Launceston General Hospital - Launceston
Recruitment hospital [19] 21338 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 36210 0
2605 - Garran
Recruitment postcode(s) [2] 36211 0
2200 - Bankstown
Recruitment postcode(s) [3] 36212 0
2065 - St Leonards
Recruitment postcode(s) [4] 36213 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 36214 0
4029 - Herston
Recruitment postcode(s) [6] 36215 0
5042 - Bedford Park
Recruitment postcode(s) [7] 36216 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 36217 0
5000 - Adelaide
Recruitment postcode(s) [9] 36218 0
3084 - Heidelberg
Recruitment postcode(s) [10] 36219 0
3550 - Bendigo
Recruitment postcode(s) [11] 36220 0
3128 - Box Hill
Recruitment postcode(s) [12] 36221 0
3168 - Clayton
Recruitment postcode(s) [13] 36222 0
3076 - Epping
Recruitment postcode(s) [14] 36223 0
3000 - Melbourne
Recruitment postcode(s) [15] 36224 0
3065 - Fitzroy
Recruitment postcode(s) [16] 36225 0
3011 - Footscray
Recruitment postcode(s) [17] 36226 0
7000 - Hobart
Recruitment postcode(s) [18] 36227 0
7250 - Launceston
Recruitment postcode(s) [19] 36228 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 24402 0
New Zealand
State/province [1] 24402 0
Auckland
Country [2] 24403 0
New Zealand
State/province [2] 24403 0
Christchurch
Country [3] 24404 0
New Zealand
State/province [3] 24404 0
Dunedin
Country [4] 24405 0
United Kingdom
State/province [4] 24405 0
Birmingham
Country [5] 24406 0
United Kingdom
State/province [5] 24406 0
Greater Manchester
Country [6] 24407 0
United Kingdom
State/province [6] 24407 0
Newcastle-upon-Tyne
Country [7] 24408 0
United Kingdom
State/province [7] 24408 0
Norwich
Country [8] 24409 0
United Kingdom
State/province [8] 24409 0
London
Country [9] 24410 0
Ireland
State/province [9] 24410 0
Dublin
Country [10] 24411 0
Sweden
State/province [10] 24411 0
Stockholm
Country [11] 24412 0
France
State/province [11] 24412 0
Lille
Country [12] 24413 0
Netherlands
State/province [12] 24413 0
Rotterdam
Country [13] 24414 0
Netherlands
State/province [13] 24414 0
Utrecht
Country [14] 24415 0
China
State/province [14] 24415 0
Hong Kong
Country [15] 24416 0
India
State/province [15] 24416 0
Vellore
Country [16] 24417 0
Malaysia
State/province [16] 24417 0
Selangor
Country [17] 24418 0
Singapore
State/province [17] 24418 0
Singapore
Country [18] 24419 0
Viet Nam
State/province [18] 24419 0
Ho Chi Minh City
Country [19] 24420 0
Canada
State/province [19] 24420 0
Toronto
Country [20] 24421 0
Canada
State/province [20] 24421 0
Montreal

Funding & Sponsors
Funding source category [1] 310380 0
Other
Name [1] 310380 0
Peter MacCallum Cancer Centre
Country [1] 310380 0
Australia
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 311522 0
None
Name [1] 311522 0
Address [1] 311522 0
Country [1] 311522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310032 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 310032 0
Ethics committee country [1] 310032 0
Australia
Date submitted for ethics approval [1] 310032 0
23/09/2021
Approval date [1] 310032 0
30/09/2021
Ethics approval number [1] 310032 0
HREC/76492/PMCC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116254 0
Dr David Liu
Address 116254 0
Division of Cancer Surgery
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000

Upper GI Surgery Unit.
Austin Health, 145 Studley Rd, Heidelberg VIC 3084,
Country 116254 0
Australia
Phone 116254 0
+61 402 857 529
Fax 116254 0
Email 116254 0
liuzdx@austin.org.au
Contact person for public queries
Name 116255 0
David Liu
Address 116255 0
Division of Cancer Surgery
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000

Upper GI Surgery Unit.
Austin Health, 145 Studley Rd, Heidelberg VIC 3084,
Country 116255 0
Australia
Phone 116255 0
+61 402 857 529
Fax 116255 0
Email 116255 0
liuzdx@austin.org.au
Contact person for scientific queries
Name 116256 0
David Liu
Address 116256 0
Division of Cancer Surgery
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000

Upper GI Surgery Unit.
Austin Health, 145 Studley Rd, Heidelberg VIC 3084,
Country 116256 0
Australia
Phone 116256 0
+61 402 857 529
Fax 116256 0
Email 116256 0
liuzdx@austin.org.au

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.