Surveillance AFter Extremity Tumor surgerY

NCT ID: NCT03944798

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2027-12-31

Brief Summary

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial randomized 310 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).

Detailed Description

Post-treatment STS surveillance is an integral element of patient care. Although earlier detection of metastatic disease may improve long-term survival, no study has yet provided definitive evidence to support this assumption. A thorough systematic review of the literature has identified only a single limited randomized controlled trial (RCT) evaluating this clinical question, and surveys of sarcoma surgeons have determined that surgeons typically follow their patients based on the way in which they were trained. The orthopaedic oncology field has identified sarcoma surveillance strategy as the top research priority in the field. In order to fill the evidence gap in sarcoma surveillance, a large international RCT is required. The investigators, therefore, propose the Surveillance AFter Extremity Tumor surgerY (SAFETY) trial. In preparation for the SAFETY trial, the SAFETY investigators have completed the following preparatory work: A) establishment of a worldwide research collaborative group that spans 6 continents; B) collection of data from international sarcoma patients to determine their perceptions of sarcoma surveillance and their willingness to participate in a study in which randomization will determine their follow-up protocols; and C) the organization of a large Protocol Development Meeting with international and multidisciplinary participation, including sarcoma patient involvement, where critical aspects of the protocol were discussed and finalized.

The international, multi-center SAFETY trial will determine the effect of surveillance strategy on patient-important outcomes after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs). Ultimately, the SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity STS patients.

Conditions

Soft Tissue Sarcoma; Lung Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Surveillance Arm I

Clinical assessment and chest radiograph (CXR) every six months for two years

Group Type: ACTIVE_COMPARATOR

Frequency: Every 6 Months

Intervention Type: OTHER

every 6 months

Imaging Modality: Chest Radiograph (CXR)

Intervention Type: OTHER

Chest radiograph (CXR)

Surveillance Arm II

Clinical assessment and CXR every three months for two years

Group Type: EXPERIMENTAL

Frequency: Every 3 Months

Intervention Type: OTHER

every 3 months

Imaging Modality: Chest Radiograph (CXR)

Intervention Type: OTHER

Chest radiograph (CXR)

Surveillance Arm III

Clinical assessment and chest computed tomography (CT) every six months for two years

Group Type: EXPERIMENTAL

Frequency: Every 6 Months

Intervention Type: OTHER

every 6 months

Imaging Modality: Chest CT

Intervention Type: OTHER

Chest computed tomography (CT)

Surveillance Arm IV

Clinical assessment and chest CT every three months for two years

Group Type: EXPERIMENTAL

Frequency: Every 3 Months

Intervention Type: OTHER

every 3 months

Imaging Modality: Chest CT

Intervention Type: OTHER

Chest computed tomography (CT)

Interventions

Frequency: Every 3 Months

every 3 months

Intervention Type: OTHER

Frequency: Every 6 Months

every 6 months

Intervention Type: OTHER

Imaging Modality: Chest Radiograph (CXR)

Chest radiograph (CXR)

Intervention Type: OTHER

Imaging Modality: Chest CT

Chest computed tomography (CT)

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Academic Health Sciences Organization

OTHER

Sponsor Role: collaborator

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

American Academy of Orthopaedic Surgeons

OTHER

Sponsor Role: collaborator

Musculoskeletal Tumor Society

UNKNOWN

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Ghert, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

University of California Davis Medical Center

Sacramento, California, United States

Hartford HealthCare

Hartford, Connecticut, United States

University of Florida Health Shands Hospital

Gainesville, Florida, United States

UChicago Medicine

Chicago, Illinois, United States

Parkview Cancer Institute

Fort Wayne, Indiana, United States

Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albany Medical Center

Albany, New York, United States

NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health and Science University Hospital

Portland, Oregon, United States

Allegheny Health Network Research Institute

Monroeville, Pennsylvania, United States

Texas Tech Health Sciences Center

El Paso, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Hospital Universitario Austral

Buenos Aires, , Argentina

St. Vincent's Hospital Melbourne

Fitzroy, Melbourne, Australia

LKH - Universitätsklinikum Graz

Graz, , Austria

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

Nova Scotia Health

Halifax, Nova Scotia, Canada

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Hôtel Dieu du Quebec

Québec, Quebec, Canada

Helios Klinikum Berlin

Berlin, , Germany

Centro Traumatologico Ortopedico Hospital

Turin, , Italy

University Malaya Kuala Lumpur

Kuala Lumpur, , Malaysia

Leiden University Medical Center

Leiden, , Netherlands

Centro Hospitalar e Universitario de Coimbra

Coimbra, , Portugal

Hospital Vall d'Hebron

Barcelona, , Spain

Karolinska University Hospital

Stockholm, , Sweden

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Germany; Italy; Malaysia; Netherlands; Portugal; Spain; Sweden

References

SAFETY Investigators. The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial. BMJ Open. 2019 Sep 18;9(9):e029054. doi: 10.1136/bmjopen-2019-029054.

Reference Type: DERIVED

PMID: 31537562 (View on PubMed)

Related Links

http://osf.io/bnfsm/

Optimal surveillance strategies following curative surgery for extremity sarcoma: A systematic review of Randomized Control Trials \[published in pre-print\].

http://osf.io/2wjyk/

Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial \[published in pre-print\].

https://osf.io/preprints/osf/6h2um

The Surveillance After Extremity Tumor Surgery (SAFETY) Pilot International Multi-Center Randomized Controlled Trial

Other Identifiers

GHRT02

Identifier Type: -

Identifier Source: org_study_id