Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 450
- Locations
- 8
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.
Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.
In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are >75 years. Despite these circumstances guidelines on patient-selection are lacking.
Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.
The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment.
Detailed Description
Hypothesis: Frailty is a predictor of poor survival Primary objective: To assess three different frailty instruments as predictors of survival Exposure: Frailty according to the three different frailty instruments evaluated Control: No frailty according to the three different frailty instruments evaluated Primary outcome measure: Overall survival
Secondary objectives (selection):
- To evaluate the effect of sarcopenia on postoperative outcome and survival
- To evaluate the effect of surgical extent on postoperative outcome and survival
- To describe the HRQoL and symptoms of the" Low anterior resection syndrome" after surgery
Phase I sub-study on the feasibility and safety of early stoma reversal (Karolinska University Hospital only)
Hypothesis: Early stoma reversal in select patients with advanced ovarian cancer is feasible and safe.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent
- •Age ≥18 years
- •Signed written informed consent
Exclusion Criteria
- •Not able to understand the Swedish or English language
- •Other diagnosis than ovarian cancer on final pathology
Arms & Interventions
Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools
Intervention: Frailty and Quality of Life evaluation (Other)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 24 months after index surgery
Overall survival time is calculated from the date of index surgery to the date of death (due to any cause), or for patients still alive to the date of last follow-up.
Secondary Outcomes
- Health related quality of life (HRQoL) (QLQ-C30)(At baseline, 12-15 weeks after index surgery and 12 months after index surgery)
- Postoperative complications(30 days after index surgery)
- Total number of hospital days and readmissions within90 days after index surgery(90 days after index surgery)
- 1-year mortality(12 months from index surgery)
- Health related quality of life (HRQoL) (QLQ-OV28)(At baseline, 12-15 weeks after index surgery and 12 months after index surgery)
- Health related quality of life (HRQoL) (QLQ-ELD14)(At baseline, 12-15 weeks after index surgery and 12 months after index surgery)
- Health related quality of life (HRQoL) (EQ-5D-5L)(At baseline, 12-15 weeks after index surgery and 12 months after index surgery)
- Readmissions(30 days after index surgery)
- Length of hospital stay(From date of index surgery to the date of discharge or at latest 90 days after index surgery)
- Extent of surgery vs survival(Up to 60 months after index surgery)
- Health economics(At baseline, 12-15 weeks after index surgery and 1 year after index surgery)
- Low anterior resection syndrome (LARS)(At baseline, 12-15 weeks after index surgery and 12 months after index surgery)
- Sarcopenia vs post-operative outcome(Up to 60 months after index surgery)
- Standard regimen of adjuvant chemotherapy(At 1 year after index surgery)
- Recurrence or progression free survival(Up to 60 months after index surgery)
- Time interval to adjuvant chemotherapy(From index surgery to first infusion of adjuvant chemotherapy)
Investigators
Sahar Salehi
MD, Associate Professor
Karolinska University Hospital