Clinical trial · Interventional
Surveillance AFter Extremity Tumor surgerY
Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Metastases | Sarcoma | PROBABILISTIC | 0.70 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frequency: Every 3 Months | Other | — | UNRESOLVED |
| Frequency: Every 6 Months | Other | — | UNRESOLVED |
| Imaging Modality: Chest CT | Other | — | UNRESOLVED |
| Imaging Modality: Chest Radiograph (CXR) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Surveillance Arm I
- description
- Clinical assessment and chest radiograph (CXR) every six months for two years
- interventionNames
- Other: Frequency: Every 6 Months
- Other: Imaging Modality: Chest Radiograph (CXR)
- type
- EXPERIMENTAL
- label
- Surveillance Arm II
- description
- Clinical assessment and CXR every three months for two years
- interventionNames
- Other: Frequency: Every 3 Months
- Other: Imaging Modality: Chest Radiograph (CXR)
- type
- EXPERIMENTAL
- label
- Surveillance Arm III
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (1)
- DERIVEDSAFETY 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