Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298877
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-26
Brief Title:
Frailty Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
Sponsor:
Sahar Salehi
Organization:
Karolinska University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOLERO
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None