Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer

Ovarian Cancer Clinical Trial

— FOLERO  

Official title:

Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298877
• Other study ID #: 2023-04696-01
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: March 28, 2029

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: Fihima M Yusuf, MSc
• Phone: +46725815883
• Email: fihima.mohamed-yusuf[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 28, 2029
• Est. primary completion date: March 28, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Frailty
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Frailty and Quality of Life evaluation
Frailty and Quality of Life evaluation after surgery

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital and Sahlgrenska Academy	Gothenburg
Sweden	Linköping University Hospital	Linköping
Sweden	Skåne University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Sahar Salehi

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	1-year mortality	Mortality within 1-year after index surgery	12 months from index surgery
Secondary	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)	At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative complications	Assessed by validated instruments, Clavien-Dindo Classification	30 days after index surgery
Secondary	Readmissions	Assessed by review of hospital records from the day of discharge after index surgery	30 days after index surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time interval to adjuvant chemotherapy	Assessed by review of hospital records.	From index surgery to first infusion of adjuvant chemotherapy
Secondary	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
Secondary	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
Secondary	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