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Fragilité, qualité de vie et inversion précoce d'une stomie défectueuse temporaire dans le cancer de l'ovaire (FOLERO)

25 septembre 2026 mis à jour par: Sahar Salehi

Fragilité, qualité de vie et inversion précoce d'une stomie défectueuse temporaire dans le cancer de l'ovaire (FOLERO) : une étude de cohorte prospective visant à déterminer l'effet de la fragilité sur la survie et à évaluer l'inversion précoce d'une stomie intestinale temporaire

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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)

Type d'étude

Interventionnel

Inscription (Estimé)

475

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Suède
      • Gothenburg, Suède, 41685
        • Recrutement
        • Sahlgrenska University Hospital and Sahlgrenska Academy
        • Contact:
        • Chercheur principal:
          • Pernilla Dahm-Kähler, MD, Prof.
        • Chercheur principal:
          • Charlotte Palmqvist, MD, PhD
      • Linköping, Suède, 581 85
      • Lund, Suède, 22185
        • Recrutement
        • Skåne University Hospital
        • Contact:
        • Chercheur principal:
          • Mihaela Asp, MD, PhD
        • Sous-enquêteur:
          • Päivi Kannisto, MD, Ass Prof
    • Solna

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Frailty

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

Frailty and Quality of Life evaluation after surgery

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Survival
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
1-year mortality
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 30 days after index surgery

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sahar Salehi

Les enquêteurs

  • Directeur d'études: Sahar Salehi, MD, PhD, Karolinska University Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 mars 2024

Achèvement primaire (Estimé)

28 mars 2030

Achèvement de l'étude (Estimé)

28 mars 2031

Dates d'inscription aux études

Première soumission

26 février 2024

Première soumission répondant aux critères de contrôle qualité

1 mars 2024

Première publication (Réel)

7 mars 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2023-04696-01
  • 2023 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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