Fragilidad, calidad de vida y reversión temprana del estoma temporal disfuncional en el cáncer de ovario (FOLERO)
Fragilidad, calidad de vida y reversión temprana del estoma temporal disfuncional en el cáncer de ovario (FOLERO): un estudio de cohorte prospectivo para determinar el efecto de la fragilidad en la supervivencia y evaluar la reversión temprana del estoma intestinal temporal
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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)
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fihima M Yusuf, MSc
- Número de teléfono: +46725815883
- Correo electrónico: fihima.mohamed-yusuf@regionstockholm.se
Ubicaciones de estudio
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Gothenburg, Suecia, 41685
- Reclutamiento
- Sahlgrenska University Hospital and Sahlgrenska Academy
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Contacto:
- Pernilla Dahm-Kähler, MD, Prof.
- Número de teléfono: 0313434216
- Correo electrónico: pernilla.dahm-kahler@gu.se
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Investigador principal:
- Pernilla Dahm-Kähler, MD, Prof.
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Investigador principal:
- Charlotte Palmqvist, MD, PhD
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Linköping, Suecia, 581 85
- Reclutamiento
- Linköping University Hospital
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Contacto:
- Madelene Wedin, MD, PhD
- Correo electrónico: madelene.wedin@regionostergotland.se
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Investigador principal:
- Madelene Wedin, MD, PhD
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Lund, Suecia, 22185
- Reclutamiento
- Skåne University Hospital
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Contacto:
- Mihaela Asp, MD, PhD
- Correo electrónico: Mihaela.Asp@skane.se
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Investigador principal:
- Mihaela Asp, MD, PhD
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Sub-Investigador:
- Päivi Kannisto, MD, Ass Prof
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Solna
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Stockholm, Solna, Suecia, 171 76
- Reclutamiento
- Karolinska University Hospital
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Contacto:
- Sahar Salehi, MD, Ass Prof
- Correo electrónico: sahar.salehi@regionstockholm.se
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Contacto:
- Daniel Hunde, MD
- Correo electrónico: daniel.hunde@regionstockholm.se
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Sub-Investigador:
- Daniel Hunde, MD
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Investigador principal:
- Sahar Salehi, MD, Ass Prof
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
Frailty and Quality of Life evaluation after surgery |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival
Periodo de tiempo: 24 months after index surgery
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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1-year mortality
Periodo de tiempo: 12 months from index surgery
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Mortality within 1-year after index surgery |
12 months from index surgery
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Health related quality of life (HRQoL) (QLQ-C30)
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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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
|
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Health related quality of life (HRQoL) (QLQ-OV28)
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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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
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Health related quality of life (HRQoL) (QLQ-ELD14)
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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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
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Health related quality of life (HRQoL) (EQ-5D-5L)
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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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
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Low anterior resection syndrome (LARS)
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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Assessed by the validated LARS questionnaire |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
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Postoperative complications
Periodo de tiempo: 30 days after index surgery
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Assessed by validated instruments, Clavien-Dindo Classification |
30 days after index surgery
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Readmissions
Periodo de tiempo: 30 days after index surgery
|
Assessed by review of hospital records from the day of discharge after index surgery |
30 days after index surgery
|
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Length of hospital stay
Periodo de tiempo: From date of index surgery to the date of discharge or at latest 90 days after index surgery
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Assessed by review of hospital records |
From date of index surgery to the date of discharge or at latest 90 days after index surgery
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Extent of surgery vs survival
Periodo de tiempo: Up to 60 months after index surgery
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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
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Sarcopenia vs post-operative outcome
Periodo de tiempo: Up to 60 months after index surgery
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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
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Standard regimen of adjuvant chemotherapy
Periodo de tiempo: At 1 year after index surgery
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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
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Time interval to adjuvant chemotherapy
Periodo de tiempo: From index surgery to first infusion of adjuvant chemotherapy
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Assessed by review of hospital records. |
From index surgery to first infusion of adjuvant chemotherapy
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Total number of hospital days and readmissions within90 days after index surgery
Periodo de tiempo: 90 days after index surgery
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Total number of hospital days within 90 days after index surgery by review of hospital records |
90 days after index surgery
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Health economics
Periodo de tiempo: At baseline, 12-15 weeks after index surgery and 1 year after index surgery
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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
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Recurrence or progression free survival
Periodo de tiempo: Up to 60 months after index surgery
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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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sahar Salehi, MD, PhD, Karolinska University Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Neoplasias Ováricas
Otros números de identificación del estudio
- 2023-04696-01
- 2023 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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