NCT06298877

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
Sahar Salehi·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Ovarian Cancer
Drug/Device/Intervention
Frailty and Quality of Life evaluation
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Sahar Salehi
Funder
Karolinska University Hospital
Location
Stockholm,Gothenburg,Linköping,Lund, Sweden
Timeline & enrollment
Phase
N/A
Start date
Mar 11, 2024
End date
Mar 28, 2029
Enrollment
450 participants
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
Malignant neoplasm of ovarySecondary malignant neoplasm of ovaryBenign neoplasm of ovaryOvarian pregnancyOvarian dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06298877
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06298877 through Pure Global AI's free database. This phase not specified trial is sponsored by Sahar Salehi and is currently Recruiting. The study focuses on Ovarian Cancer. Target enrollment is 450 participants.

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