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

Sahar Salehi450 enrolled

Overview

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.

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. Primary objective: To assess the feasibility and safety of early closure of defunctioning stoma after upfront cytoreductive surgery in ovarian cancer Primary outcome measure : Feasibility and safety of early stoma reversal as measured by rate of anastomotic leakage, urgent re- operations and time-interval to adjuvant chemotherapy (defined cut-offs based on historic comparison in the study protocol)

Locations (4)

Karolinska University Hospital

Stockholm, Solna, Sweden

RECRUITING

Sahlgrenska University Hospital and Sahlgrenska Academy

Gothenburg, Sweden

NOT_YET_RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Overall Survival

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.

Time frame: 24 months after index surgery

Secondary Outcomes

1-year mortality

Mortality within 1-year after index surgery

Time frame: 12 months from index surgery

Health related quality of life (HRQoL) (QLQ-C30)

Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), Core Questionnaire (QLQ-C30)