Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age55-110
SponsorPopulation Health Research Institute
About this trial
FARGO is a prospective cohort study that aims to determine the performance of preoperative frailty assessment based on the Frailty Phenotype (FP), compared to a perioperative cardiovascular risk assessment based on the combination of preoperative Revised Cardiac Risk Index (RCRI), age and occurrence of myocardial injury after noncardiac surgery (MINS), in predicting the composite of all-cause death or new disability at 6 months after surgery in patients aged 55 or older. Patients will have confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age must be 55 years or older at registration
Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT)
Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible/high-risk due to comorbidities
Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or
Disqualifiers
Unable to provide informed consent
Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team
Are undergoing neoadjuvant radiation therapy
Have a previously documented history of dementia
Trial population
FARGO will recruit patients aged 55 or older, with confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical Frailty Scale
Diagnostic testA way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician
Frailty Phenotype
Diagnostic testDefined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity
Treatment groups
280 Participants
are divided into 4 treatment groupsGroup A: Group A2 interventions
Group B: Group B2 interventions
Group C: Group C2 interventions
Group D: Group D2 interventions
Trial outcomes
Primary outcomes
1
All-cause death or new disability at 6 months
Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores: 1. For individuals with a disability score of \<25% at baseline, new disability is defined as a disability score ≥25% at follow-up; 2. For individuals with a disability score ≥25%, new disability is defined an increase in disability score of ≥8%. Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g. trauma, infection, malignancy).
Time frame
6 monthsSecondary outcomes
1
All cause death
Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g., trauma, infection, malignancy).
Time frame
28 days and 1 year2
Oncologic Outcomes: Progression Free Survival (PFS)
PFS, defined as the time from treatment initiation to tumor progression or recurrence or death from any cause, or to the date of censoring at the last time the subject was known to be alive. Cancer progression/recurrence will be defined as a measurable progression/recurrence documented on imaging.
Time frame
at 6 and 12 months3
Oncologic Outcomes: Cancer-specific death
Cancer-specific death is death directly attributable to the primary gynecological cancer or directly related to its treatment, in the absence of other causes of death.
Time frame
at 6 and 12 months4
New Disability
Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores: 1. For individuals with a disability score of \<25% at baseline, new disability is defined as a disability score ≥25% at follow-up; 2. For individuals with a disability score ≥25%, new disability is defined an increase in disability score of ≥8%. Definition of new disability at 28 days, 6 months, and 1 year after surgery will use as baseline disability score the WHODAS 2.0 score measured before surgery.
Time frame
28 days, 6 months and 1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov