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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.
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):
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frailty | Experimental | Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frailty and Quality of Life evaluation | Other | Frailty and Quality of Life evaluation after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year mortality | Mortality within 1-year after index surgery | 12 months from index surgery |
| Health related quality of life (HRQoL) (QLQ-C30) | Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), Core Questionnaire (QLQ-C30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fihima M Yusuf, MSc | Contact | +46725815883 | fihima.mohamed-yusuf@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Sahar Salehi, MD, PhD | Karolinska University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | Solna | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39907536 | Derived | Hunde D, Ekerstad N, Asp M, Kannisto P, Wedin M, Palmqvist C, Dahm-Kahler P, Brandberg Y, Abraham-Nordling M, Ahlund K, Morlin V, Groes-Kofoed N, Salehi S. Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO). Acta Oncol. 2025 Feb 5;64:208-213. doi: 10.2340/1651-226X.2025.42292. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| At baseline, 12-15 weeks after index surgery and 12 months after index surgery |
| Health related quality of life (HRQoL) (QLQ-OV28) | 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) | 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) | 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) | Assessed by the validated LARS questionnaire | At baseline, 12-15 weeks after index surgery and 12 months after index surgery |
| Postoperative complications | Assessed by validated instruments, Clavien-Dindo Classification | 30 days after index surgery |
| Readmissions | Assessed by review of hospital records from the day of discharge after index surgery | 30 days after index surgery |
| Length of hospital stay | 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 | 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 | 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 | 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 | 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 | Total number of hospital days within 90 days after index surgery by review of hospital records | 90 days after index surgery |
| Health economics | 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 | 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 |
| Sahlgrenska University Hospital and Sahlgrenska Academy | Not yet recruiting | Gothenburg | 41685 | Sweden |
|
| Linköping University Hospital | Recruiting | Linköping | 581 85 | Sweden |
|
| Skåne University Hospital | Not yet recruiting | Lund | 22185 | Sweden |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |