Soft Tissue Sarcoma Clinical Trial
— SAFETYOfficial title:
Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
NCT number | NCT03944798 |
Other study ID # | GHRT02 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 19, 2019 |
Est. completion date | December 2030 |
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 will randomize 830 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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2030 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Universitario Austral | Buenos Aires | |
Australia | St. Vincent's Hospital Melbourne | Fitzroy | Melbourne |
Austria | LKH - Universitätsklinikum Graz | Graz | |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | |
Canada | Nova Scotia Health | Halifax | Nova Scotia |
Canada | Juravinski Hospital and Cancer Centre | Hamilton | Ontario |
Canada | Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Hôtel Dieu du Quebec | Québec | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Italy | Centro Traumatologico Ortopedico Hospital | Turin | |
Netherlands | Leiden University Medical Center | Leiden | |
United States | Albany Medical Center | Albany | New York |
United States | Montefiore Medical Center | Bronx | New York |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Texas Tech Health Sciences Center | El Paso | Texas |
United States | Virginia Cancer Specialists | Fairfax | Virginia |
United States | Parkview Cancer Institute | Fort Wayne | Indiana |
United States | University of Florida Health Shands Hospital | Gainesville | Florida |
United States | Hartford HealthCare | Hartford | Connecticut |
United States | Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center | New York | New York |
United States | Oregon Health and Science University Hospital | Portland | Oregon |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Hamilton Academic Health Sciences Organization |
United States, Argentina, Australia, Austria, Brazil, Canada, Italy, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | as measured by death from any cause. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | Metastasis-Free Survival | As measured by as the length of time from the time of randomization that the participant survives with no detection of systemic disease recurrence at any anatomic location. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | Net Healthcare Costs | Will include both the net costs of surveillance and costs incurred from metastasis treatment and metastasis treatment-related complications. | 5 years |
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