Clinical trial NCT06298877: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 24 months after index surgery
Secondary outcomes:
measure: 1-year mortality
timeFrame: 12 months from index surgery
measure: Health related quality of life (HRQoL) (QLQ-C30)
timeFrame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
measure: Health related quality of life (HRQoL) (QLQ-OV28)
timeFrame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
measure: Health related quality of life (HRQoL) (QLQ-ELD14)
timeFrame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
measure: Health related quality of life (HRQoL) (EQ-5D-5L)
timeFrame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
measure: Low anterior resection syndrome (LARS)
timeFrame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
measure: Postoperative complications
timeFrame: 30 days after index surgery
measure: Readmissions
timeFrame: 30 days after index surgery
measure: Length of hospital stay
timeFrame: From date of index surgery to the date of discharge or at latest 90 days after index surgery
measure: Extent of surgery vs survival
timeFrame: Up to 60 months after index surgery
measure: Sarcopenia vs post-operative outcome
timeFrame: Up to 60 months after index surgery
measure: Standard regimen of adjuvant chemotherapy
timeFrame: At 1 year after index surgery
measure: Time interval to adjuvant chemotherapy
timeFrame: From index surgery to first infusion of adjuvant chemotherapy
measure: Total number of hospital days and readmissions within90 days after index surgery
timeFrame: 90 days after index surgery
measure: Health economics
timeFrame: At baseline, 12-15 weeks after index surgery and 1 year after index surgery
measure: Recurrence or progression free survival
timeFrame: Up to 60 months after index surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Solna
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital and Sahlgrenska Academy
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Sahar Salehi, MD, PhD
role: STUDY_DIRECTOR
References: