Clinical trial · Interventional
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frailty and Quality of Life evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Frailty
- description
- Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools
- interventionNames
- Other: Frailty and Quality of Life evaluation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months after index surgery
- description
- 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 (16)
- measure
- 1-year mortality
- timeFrame
- 12 months from index surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHunde D, Ekerstad N, Asp M, Kannisto P, Wedin M, Palmqvist C, Dahm-Kahler P, Brandberg Y, Abraham-Nordling M, Ahlund K, Morlin V, Groes-Kofoed N, Salehi S. Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO). Acta Oncol. 2025 Feb 5;64:208-213. doi: 10.2340/1651-226X.2025.42292. PMID 39907536