NCT06298877 Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
| NCT ID | NCT06298877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahar Salehi |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2029-03-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2024-03-11 with a primary completion date of 2029-03-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Sahar Salehi, MD, PhD
STUDY DIRECTOR
Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT06298877 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06298877 currently recruiting?
Yes, NCT06298877 is actively recruiting participants. Contact the research team at fihima.mohamed-yusuf@regionstockholm.se for enrollment information.
Where is the NCT06298877 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Gothenburg, Sweden, Linköping, Sweden, Lund, Sweden.
Who is sponsoring the NCT06298877 clinical trial?
NCT06298877 is sponsored by Sahar Salehi. The principal investigator is Sahar Salehi, MD, PhD at Karolinska University Hospital. The trial plans to enroll 450 participants.
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