An interventional study of Frequency: Every 3 Months and Frequency: Every 6 Months in Soft Tissue Sarcoma and Lung Metastases, sponsored by McMaster University. Active, not recruiting at 35 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by McMaster University · Not applicable, Interventional, and Prevention
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).
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.
1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 310 is above the median of 40 across 1,300 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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;
Clinical assessment and chest radiograph (CXR) every six months for two years
Other: Frequency: Every 6 Months · Other: Imaging Modality: Chest Radiograph (CXR)
Clinical assessment and CXR every three months for two years
Other: Frequency: Every 3 Months · Other: Imaging Modality: Chest Radiograph (CXR)
Clinical assessment and chest computed tomography (CT) every six months for two years
Other: Frequency: Every 6 Months · Other: Imaging Modality: Chest CT
Clinical assessment and chest CT every three months for two years
Other: Frequency: Every 3 Months · Other: Imaging Modality: Chest CT
every 3 months
every 6 months
Chest radiograph (CXR)
Chest computed tomography (CT)
Hierarchal Composite Outcome of Patient-Important Outcomes
The composite outcome consists of overall survival, serious adverse events, and patient-reported cancer-related anxiety
Time frame: 3 years post randomization
Patient Anxiety
The PROMIS® Cancer-Anxiety instrument assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS® Cancer-Anxiety instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's responses will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of anxiety.
Time frame: 3 years
Patient Satisfaction
The PROMIS® Satisfaction with Social Roles \& Activities instrument assesses satisfaction with performing one's usual social roles and activities (e.g., 'I am satisfied with my ability to participate in family activities'). This instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's response will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest possible raw score is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of satisfaction.
Time frame: 3 years
Patient Quality-of-Life
The validated EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaire measures generic health status and consists of 2 sections: the descriptive system and the Visual Analogue Scale (VAS). The descriptive system is comprised of 5 dimensions (mobility, self care, usual activities, pain / discomfort and anxiety / depression). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 5 and the highest is 25. A lower raw score in the descriptive system represents fewer issues with each of the 5 domains. The VAS records a participant's self-rated health from 0 to 100 on a vertical VAS with endpoints labeled '100 - the best health you can imagine' and '0 - the worst health you can imagine'. The participant is asked to mark an 'X' on the scale and write the corresponding number, which is this section's raw score.
Time frame: 3 years
Local Recurrence-Free Survival
As measured by the length of time from the time of randomization that the participant survives with no detection of recurrent disease at the initial tumor site or operative field.
Time frame: 3 years
Metastasis-Free Survival
As measured by the length of time from the time of randomization that the participant survives with no detection of systemic disease recurrence at any anatomic location.
Time frame: 3 years
Treatment-Related Complications
Will include both chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax, or surgical site infections.
Time frame: 3 years
Net Healthcare Costs
Will include both the net costs of surveillance and costs incurred from metastasis treatment and metastasis treatment-related complications.
Time frame: 3 years
Plan to share: Undecided
Started Nov 2019 (actual). Primary completion is estimated for Dec 2027, 97 months after the start.
Of 147 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 120. This study's planned 97 months is above that.
Counting every sponsor, half of 150 studies reached it within 59 months; a quarter within 29 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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