Surveillance AFter Extremity Tumor surgerY

NCT03944798 | Active Not Recruiting DMC

• 1 other identifier: GHRT02
• Study Type: interventional
• Target: 310
• Locations: 13 countries
• Sites: 34

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).

Conditions

Soft Tissue Sarcoma; Lung Metastases

Keywords

Soft Tissue Sarcoma; Lung Metastases; Overall Survival; Surveillance; Randomized Controlled Trial; Patient Anxiety; Serious Adverse Events

Outcome Measures

Primary Outcomes (1)

• Hierarchal Composite Outcome of Patient-Important Outcomes

  The composite outcome consists of overall survival, serious adverse events, and patient-reported cancer-related anxiety

  3 years post randomization

Secondary Outcomes (7)

• Patient Anxiety

  3 years

• Patient Satisfaction

  3 years

• Patient Quality-of-Life

  3 years

• Local Recurrence-Free Survival

  3 years

• Metastasis-Free Survival

  3 years

Study Arms (4)

Surveillance Arm I

ACTIVE COMPARATOR

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

Other: Frequency: Every 6 Months; Other: Imaging Modality: Chest Radiograph (CXR)

Surveillance Arm II

EXPERIMENTAL

Clinical assessment and CXR every three months for two years

Other: Frequency: Every 3 Months; Other: Imaging Modality: Chest Radiograph (CXR)

Surveillance Arm III

EXPERIMENTAL

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

Other: Frequency: Every 6 Months; Other: Imaging Modality: Chest CT

Surveillance Arm IV

EXPERIMENTAL

Clinical assessment and chest CT every three months for two years

Other: Frequency: Every 3 Months; Other: Imaging Modality: Chest CT

Interventions

Frequency: Every 3 Months OTHER

every 3 months

Surveillance Arm II; Surveillance Arm IV

Frequency: Every 6 Months OTHER

every 6 months

Surveillance Arm I; Surveillance Arm III

Imaging Modality: Chest Radiograph (CXR) OTHER

Chest radiograph (CXR)

Surveillance Arm I; Surveillance Arm II

Imaging Modality: Chest CT OTHER

Chest computed tomography (CT)

Surveillance Arm III; Surveillance Arm IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• American Academy of Orthopaedic Surgeons: collaborator
• Musculoskeletal Tumor Society: collaborator

Study Sites (35)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Hartford HealthCare

Hartford, Connecticut, 06102, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

UChicago Medicine

Chicago, Illinois, 60637, United States

Location

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center

New York, New York, 10010, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

Allegheny Health Network Research Institute

Monroeville, Pennsylvania, 15212, United States

Location

Texas Tech Health Sciences Center

El Paso, Texas, 79905, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Hospital Universitario Austral

Buenos Aires, Argentina

Location

St. Vincent's Hospital Melbourne

Fitzroy, Melbourne, 3065, Australia

Location

LKH - Universitätsklinikum Graz

Graz, 8036, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

Nova Scotia Health

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V1C3, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Hôtel Dieu du Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Helios Klinikum Berlin

Berlin, Germany

Location

Centro Traumatologico Ortopedico Hospital

Turin, Italy

Location

University Malaya Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Centro Hospitalar e Universitario de Coimbra

Coimbra, Portugal

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31537562 DERIVED

Related Links

• Optimal surveillance strategies following curative surgery for extremity sarcoma: A systematic review of Randomized Control Trials \[published in pre-print\].
• Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial \[published in pre-print\].
• The Surveillance After Extremity Tumor Surgery (SAFETY) Pilot International Multi-Center Randomized Controlled Trial

MeSH Terms

Conditions

Sarcoma

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Michelle Ghert, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The local clinical team, site study personnel and participants cannot be blinded to the treatment allocation as the imaging modalities are visually distinguishable and these individuals will be required to arrange the booking of surveillance visits and imaging at their respective clinical site. The Central Adjudication Committee (CAC) will be blinded to surveillance frequency; however, because the imaging modalities are visually distinguishable, the CAC cannot be blinded to imaging modality. The data analysts will, however, remain blinded throughout the trial and all interpretation of study results will be conducted in a blinded manner. Since the primary outcome is objective, a lack of blinding of study personnel and patients, and the incomplete blinding of outcome assessors, introduces minimal threats to validity.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 2 factorial superiority randomized controlled trial

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: November 19, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

BR (1); AR (1); IT (1); NL (1); PT (1); CA (7); MY (1); DE (1); ES (1); SE (1); AU (1); BE (1); US (16)