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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03944798


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT03944798
Ethics application status
Date submitted
7/05/2019
Date registered
10/05/2019

Titles & IDs
Public title
Surveillance AFter Extremity Tumor surgerY
Scientific title
Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
Secondary ID [1] 0 0
GHRT02
Universal Trial Number (UTN)
Trial acronym
SAFETY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Sarcoma 0 0
Lung Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Frequency: Every 3 Months
Other interventions - Frequency: Every 6 Months
Other interventions - Imaging Modality: Chest Radiograph (CXR)
Other interventions - Imaging Modality: Chest CT

Active comparator: Surveillance Arm I - Clinical assessment and chest radiograph (CXR) every six months for two years

Experimental: Surveillance Arm II - Clinical assessment and CXR every three months for two years

Experimental: Surveillance Arm III - Clinical assessment and chest computed tomography (CT) every six months for two years

Experimental: Surveillance Arm IV - Clinical assessment and chest CT every three months for two years


Other interventions: Frequency: Every 3 Months
every 3 months

Other interventions: Frequency: Every 6 Months
every 6 months

Other interventions: Imaging Modality: Chest Radiograph (CXR)
Chest radiograph (CXR)

Other interventions: Imaging Modality: Chest CT
Chest computed tomography (CT)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Patient Anxiety
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Patient Satisfaction
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Patient Quality-of-Life
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Local Recurrence-Free Survival
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Metastasis-Free Survival
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Treatment-Related Complications
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Net Healthcare Costs
Timepoint [7] 0 0
5 years

Eligibility
Key inclusion criteria
* The patient is 18 years of age or older;
* The patient has been diagnosed with a primary extremity grade II or III soft-tissue sarcoma (STS);
* The patient has undergone surgical excision of the tumor with curative intent and with no evidence of gross residual disease based on the pathology report;
* The patient has completed all planned neoadjuvant or adjuvant radiation and / or chemotherapy, if applicable;
* The tumor size is greater than or equal to (=) five centimeters according to the pathology report or based on the pre-treatment MRI if neoadjuvant radiation and / or chemotherapy are given; and
* The patient provides informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†;
* The patient has recently undergone surgical excision of a local recurrence;
* The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma*;
* The patient has been previously diagnosed with a genetic syndrome with an elevated risk of malignancy, such as Li-Freumeni Syndrome‡;
* The patient has been previously diagnosed with a co-morbid condition that has a life expectancy of less than (<) one year;
* The site-specific surveillance protocol for the patient's disease is not compatible with the study protocol (i.e., regular planned whole-body imaging with positron emission tomography [PET] scans);
* Likely problems, in the judgment of the investigator, with the patient maintaining follow-up (with the specific reasoning requiring approval of the Methods Center);
* The patient is currently enrolled in a study that does not permit co-enrolment; and
* The patient has already been enrolled in the SAFETY trial.

* A second CT scan may be required to confirm that indeterminate nodules are false positives before the patient can be enrolled (provided that the second CT scan shows no evidence of metastatic disease);

* Myxoid liposarcoma and extra-skeletal Ewing's sarcoma have different metastatic patterns, which necessitate different surveillance protocols;

* Individuals with Li-Freumeni Syndrome, or other genetic syndromes with an elevated risk of malignancy, appear to be at an elevated risk for radiation-induced cancers, so the use of CT scans should be limited.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Melbourn
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Italy
State/province [18] 0 0
Turin
Country [19] 0 0
Netherlands
State/province [19] 0 0
Leiden

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hamilton Academic Health Sciences Organization
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michelle Ghert, MD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hadia Farrukh
Address 0 0
Country 0 0
Phone 0 0
(905) 521-2100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03944798

Additional trial details provided through ANZCTR
Accrual to date
71
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 36
St Vincent's Hospital (Melbourne) Ltd
Recruitment postcode(s) [1] 41
3065
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
Hamilton Academic Health Sciences Organisation (HAHSO)
Primary sponsor address
HAHSO
c/o McMaster University
HSC-2E22, 1280 Main St. W.
Hamilton, ON L8S 4K1
Canada.
Primary sponsor country
Canada
Secondary sponsor category [1] 53
Charities/Societies/Foundations
Name [1] 53
Canadian Cancer Society Research Institute (CCSRI)
Address [1] 53
Suite 300, 55 St. Claire Avenue W. Toronto, Ontario. M4V 2Y7 Canada.
Country [1] 53
Canada
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 32
HiREB: Hamilton Integrated Research Ethics Board
Address [1] 32
293 Wellington Street North Suite 120 Hamilton, Ontario. Canada. L8L 8E7
Country [1] 32
Canada
Date submitted for ethics approval [1] 32
Approval date [1] 32
27/08/2019
Ethics approval number [1] 32
Project Number: 7562
Ethics committee name [2] 33
St Vincent's HREC
Address [2] 33
Research Governance Unit St Vincent's Hospital, Melbourne. 41 Victoria Parade Fitzroy VIC 3065. PO Box 2900 Fitzroy VIC 3065.
Country [2] 33
Date submitted for ethics approval [2] 33
29/03/2021
Approval date [2] 33
19/10/2021
Ethics approval number [2] 33
Project ID: 72769, HREC: 085/21
 
Public notes

Contacts
Principal investigator
Title 269 0
Prof
Name 269 0
Peter Choong
Address 269 0
Department of Surgery I St Vincent’s Hospital Melbourne Level 2, Clinical Sciences Building 29 Regent Street, Fitzroy 3065, Victoria, Australia
Country 269 0
Australia
Phone 269 0
+61392312364
Fax 269 0
+61392312131
Email 269 0
[email protected]
Contact person for public queries
Title 270 0
Mrs
Name 270 0
Angela Cochrane
Address 270 0
Department of Surgery, St Vincent's Hospital, level 3, Daly Wing 35 Victoria Parade, Fitzroy. Victoria, 3065. Australia
Country 270 0
Australia
Phone 270 0
+61392312364
Fax 270 0
+61392312131
Email 270 0
[email protected]
Contact person for scientific queries
Title 271 0
Ms
Name 271 0
Tricia Schneider
Address 271 0
McMaster University
Country 271 0
Canada
Phone 271 0
Fax 271 0
Email 271 0
[email protected]