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
- Ovarian Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Sahar Salehi
- Enrolment target
- 475
- Started
- 11 March 2024
- Main results due
- 28 March 2030
- Study sites
- 4
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(4)
Karolinska University Hospital
Stockholm, Solna, Sweden
Recruiting
Sahlgrenska University Hospital and Sahlgrenska Academy
Gothenburg, Sweden
Recruiting
Linköping University Hospital
Linköping, Sweden
Recruiting
Skåne University Hospital
Lund, Sweden
Recruiting
Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06298877. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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