Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial
Bibliographic record
Abstract
Title: Surveillance AFter Extremity Tumor surgerY International Randomized Controlled Trial Short Title: SAFETY Methodology: Multi-center, 2 x 2 factorial superiority randomized controlled trial (RCT). Coordinating Center: This study will be centrally coordinated by the Methods Center at the Center for Evidence-Based Orthopaedics (CEO) at McMaster University in Hamilton, Ontario Canada. Clinical Sites: We are expecting ten clinical sites to be involved in the pilot phase. Further sites will be recruited for the definitive phase. Primary Objectives: The overall objective is to determine the effect of surveillance strategy on patient survival after surgery for a soft-tissue sarcoma of the extremity by comparing the effectiveness of: A) a surveillance frequency of every three months vs. every six months; and B) CT scans vs. chest radiographs. Secondary Objectives: We will explore: A) the effects of the post-operative surveillance strategies on patient-important outcomes (patient anxiety, overall satisfaction and quality of life), oncologic outcomes (local recurrence- and metastasis-free survival) and treatment-related complications (chemotherapy- and thoracotomy-related complications); and B) the net costs of post-operative surveillance strategies and of metastasis treatment and treatment-related complications. Treatment Groups: This study will compare two surveillance frequencies (every three months vs. every six months) and two imaging modalities (CT scan vs. chest radiograph) for a total of four treatment groups: 1) Surveillance visit and chest CT scan every three months for two years; 2) Surveillance visit and chest CT scan every six months for two years; 3) Surveillance visit and chest radiograph every three months for two years; or 4) Surveillance visit and chest radiograph every six months for two years. Study Outcome: The primary outcome is overall survival at five years post-randomization. Follow-Up: Upon completion of the two-year intervention phase, study participants will be followed every six months for another three years. Sample Size: Pilot - 200 participants | Definitive - 830 participants Estimated Study Duration: Pilot - September 2019 – January 2023 | Definitive - TBD Significance: 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. 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 soft-tissue sarcoma patients.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.090 | 0.082 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.011 | 0.008 |
| Bibliometrics | 0.004 | 0.006 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.006 | 0.006 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.011 | 0.012 |
| Insufficient payload (model declined to judge) | 0.099 | 0.017 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".