soft tissue sarcoma - soft tissue cancer
Conditions
Interventions
Participants will be randomized to one of four treatment / surveillance groups:
1) Clinical assessment and CXR every three months for two years
2) Clinical assessment and CXR every six months for two years
3) Clinical assessment and Chest CT every three months for two years
or
4) Clinical assessment and Chest CT every six months for two years.
Sponsors
Hamilton Academic Health Sciences Organization
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients who satisfy all of the eligibility criteria outlined below are to be included in the SAFETY trial: 1) The patient is 18 years of age or older; 2) The patient has been diagnosed with a primary extremity grade II or III STS; 3) 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; 4) The patient has completed all planned neoadjuvant or adjuvant radiation and / or chemotherapy, if applicable; 5) 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
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not to be included in the SAFETY trial: 1) The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging; 2) The patient has recently undergone surgical excision of a local recurrence; 3) The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing*s sarcoma; 4) The patient has been previously diagnosed with a genetic syndrome with an elevated risk of malignancy, such as Li-Freumeni Syndrome*; 5) The patient has been previously diagnosed with a co-morbid condition that has a life expectancy of less than one year; 6) 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); 7) Likely problems, in the judgment of the investigator, with the patient maintaining follow-up (with the specific reasoning requiring approval of the Methods Center); 8) The patient is currently enrolled in a study that does not permit co-enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for the definitive trial will be overall five-year survival. The primary outcome measure will be death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Anxiety Outcome Measure: The validated Patient-Reported Outcomes Measurement Information System (PROMIS)® Cancer-Anxiety questionnaire will be used to assess patient anxiety. This questionnaire will be administered at the baseline visit, as well as the 6-month, 12-month, 18-month and 24-month intervention phase and 36-month, 48-month and 60-month post-intervention phase visits. Patient Overall Satisfaction Outcome Measure: The validated PROMIS® Satisfaction with Social Roles and Activities questionnaire will be used to assess patient overall satisfaction. This questionnaire will be administered at the baseline visit, as well as the 6-month, 12-month, 18-month and 24-month intervention phase and 36-month, 48-month and 60-month post-intervention phase visits. Quality of Life Outcome Measure: The validated EuroQol-5 Dimension (EQ-5D) will be used to assess patient quality of life. This questionnaire will be administered at the baseline visit, as well as the 6-month, 12-month, 18-month and 24-month intervention phase and 36-month, 48-month and 60-month post-intervention phase visits. Local Recurrence-Free Survival (LRFS) Outcome Measure: LRFS will be defined as 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. Local disease recurrence and the modality in which it was identified (i.e. physical exam, MRI, ultrasound) will be documented on participant case report forms (CRFs). Metastasis-Free Survival (MFS) Outcome Measure: MFS will be defined 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. Systemic disease recurrence and the modality in which it was identified (CXR, CT, PET scan, bone scan) will be documented on participant CRFs. Treatment-Related Complications Outcome Measures: Treatment-related complications will | — |
Countries
Netherlands
Outcome results
None listed