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Skörhet, livskvalitet och tidig reversering av tillfälligt defungerande stomi vid äggstockscancer (FOLERO)

25 september 2026 uppdaterad av: Sahar Salehi

Skörhet, livskvalitet och tidig reversering av tillfälligt defungerande stomi i äggstockscancer (FOLERO): En prospektiv kohortstudie för att fastställa effekten av skröplighet på överlevnad och för att bedöma tidig reversering av tillfällig intestinal stomi

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

Studietyp

Interventionell

Inskrivning (Beräknad)

475

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Sverige
      • Gothenburg, Sverige, 41685
        • Rekrytering
        • Sahlgrenska University Hospital and Sahlgrenska Academy
        • Kontakt:
        • Huvudutredare:
          • Pernilla Dahm-Kähler, MD, Prof.
        • Huvudutredare:
          • Charlotte Palmqvist, MD, PhD
      • Linköping, Sverige, 581 85
      • Lund, Sverige, 22185
        • Rekrytering
        • Skåne University Hospital
        • Kontakt:
        • Huvudutredare:
          • Mihaela Asp, MD, PhD
        • Underutredare:
          • Päivi Kannisto, MD, Ass Prof
    • Solna

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Frailty

Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools
Övrig: Frailty and Quality of Life evaluation

Frailty and Quality of Life evaluation after surgery

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: 24 months after index surgery

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.
24 months after index surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
1-year mortality
Tidsram: 12 months from index surgery

Mortality within 1-year after index surgery
12 months from index surgery
Health related quality of life (HRQoL) (QLQ-C30)
Tidsram: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), Core Questionnaire (QLQ-C30)
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (QLQ-OV28)
Tidsram: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), EORTC Quality of life Questionnaire Ovarian Cancer Module (QLQ)-OV28
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (QLQ-ELD14)
Tidsram: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), EORTC Quality of life Questionnaire Elderly Module (EORTC-QLQ-ELD14)
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (EQ-5D-5L)
Tidsram: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), EQ-5D-5L
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Low anterior resection syndrome (LARS)
Tidsram: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Assessed by the validated LARS questionnaire
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Postoperative complications
Tidsram: 30 days after index surgery

Assessed by validated instruments, Clavien-Dindo Classification
30 days after index surgery
Readmissions
Tidsram: 30 days after index surgery

Assessed by review of hospital records from the day of discharge after index surgery
30 days after index surgery
Length of hospital stay
Tidsram: From date of index surgery to the date of discharge or at latest 90 days after index surgery

Assessed by review of hospital records
From date of index surgery to the date of discharge or at latest 90 days after index surgery
Extent of surgery vs survival
Tidsram: Up to 60 months after index surgery

Measured by surgical complexity score (as defined by the Mayo and Karolinska Surgical Complexity scores) and Peritoneal Cancer Index (PCI) both by assessment at the preoperative multidisciplinary conference

The agreement between preoperative and peroperative assessment of surgical extent needed to achive complete macroscopic resection.
Up to 60 months after index surgery
Sarcopenia vs post-operative outcome
Tidsram: Up to 60 months after index surgery

Sarcopenia is measured by computed tomography and different muscle groups by different software programs (e.g. Coreslicer, Slice-o-matic etc.).
Up to 60 months after index surgery
Standard regimen of adjuvant chemotherapy
Tidsram: At 1 year after index surgery

Standard regimen of adjuvant chemotherapy is defined as Carboplatin (AUC 5) and Paclitaxel (175 mg/m2) every 21 days for 6 cycles. Dose and frequency will be assessed by review of hospital records
At 1 year after index surgery
Time interval to adjuvant chemotherapy
Tidsram: From index surgery to first infusion of adjuvant chemotherapy

Assessed by review of hospital records.
From index surgery to first infusion of adjuvant chemotherapy
Total number of hospital days and readmissions within90 days after index surgery
Tidsram: 90 days after index surgery

Total number of hospital days within 90 days after index surgery by review of hospital records
90 days after index surgery
Health economics
Tidsram: At baseline, 12-15 weeks after index surgery and 1 year after index surgery

Health economics will be assessed by the Eq5D-5L validated instrument
At baseline, 12-15 weeks after index surgery and 1 year after index surgery
Recurrence or progression free survival
Tidsram: Up to 60 months after index surgery

Defined as the time interval between index surgery and the date of recurrence or death, whichever comes first. For event-free patients recurrence free survival is the time between index surgery and the date for the last follow-up visit by review of medical records.
Up to 60 months after index surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sahar Salehi

Utredare

  • Studierektor: Sahar Salehi, MD, PhD, Karolinska University Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 mars 2024

Primärt slutförande (Beräknad)

28 mars 2030

Avslutad studie (Beräknad)

28 mars 2031

Studieregistreringsdatum

Först inskickad

26 februari 2024

Först inskickad som uppfyllde QC-kriterierna

1 mars 2024

Första postat (Faktisk)

7 mars 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2023-04696-01
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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