Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer - Trial NCT06298877

Timeline & Enrollment

Primary Outcome

Overall Survival

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.

ICD-10 Classifications