Trial Title:
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
NCT ID:
NCT06298877
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Frailty and Quality of Life evaluation
Description:
Frailty and Quality of Life evaluation after surgery
Arm group label:
Frailty
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)
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Sahar Salehi, MD, Ass Prof
Email:
sahar.salehi@regionstockholm.se
Contact backup:
Last name:
Daniel Hunde, MD
Email:
daniel.hunde@regionstockholm.se
Investigator:
Last name:
Daniel Hunde, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sahar Salehi, MD, Ass Prof
Email:
Principal Investigator
Facility:
Name:
Sahlgrenska University Hospital and Sahlgrenska Academy
Address:
City:
Gothenburg
Zip:
41685
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Pernilla Dahm-Kähler, MD, Prof.
Phone:
0313434216
Email:
pernilla.dahm-kahler@gu.se
Investigator:
Last name:
Pernilla Dahm-Kähler, MD, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Charlotte Palmqvist, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Linköping University Hospital
Address:
City:
Linköping
Zip:
581 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Madelene Wedin, MD, PhD
Email:
madelene.wedin@regionostergotland.se
Investigator:
Last name:
Madelene Wedin, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Skåne University Hospital
Address:
City:
Lund
Zip:
22185
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Mihaela Asp, MD, PhD
Email:
Mihaela.Asp@skane.se
Investigator:
Last name:
Mihaela Asp, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Päivi Kannisto, MD, Ass Prof
Email:
Sub-Investigator
Start date:
March 11, 2024
Completion date:
March 28, 2029
Lead sponsor:
Agency:
Sahar Salehi
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06298877
