Ovarian CancerFOLERONCT06298877
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
A study testing Frailty and Quality of Life evaluation in people with Ovarian Cancer, run by Sahar Salehi at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Frailty and Quality of Life evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 4 sitesSweden
- Study dates
- 11 Mar 2024to 28 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent
- Age ≥18 years
- Signed written informed consent
Who cannot join
- Not able to understand the Swedish or English language
- Other diagnosis than ovarian cancer on final pathology
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital and Sahlgrenska Academy
Gothenburg, 41685
Pernilla Dahm-Kähler, MD, Prof., 0313434216, pernilla.dahm-kahler@gu.se
Pernilla Dahm-Kähler, MD, Prof.
- Recruiting
Linköping University Hospital
Linköping, 581 85
Madelene Wedin, MD, PhD, madelene.wedin@regionostergotland.se
Madelene Wedin, MD, PhD
- Recruiting
Skåne University Hospital
Lund, 22185
Mihaela Asp, MD, PhD, Mihaela.Asp@skane.se
Mihaela Asp, MD, PhD
- Recruiting
Karolinska University Hospital
Stockholm, Solna, 171 76
Sahar Salehi, MD, Ass Prof, sahar.salehi@regionstockholm.se
Daniel Hunde, MD, daniel.hunde@regionstockholm.se
About this study
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
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.
Read more
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.
Read the 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)
- Conditions
- Ovarian Cancer
- Being tested
- Frailty and Quality of Life evaluation
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty and Quality of Life evaluationOther
Frailty and Quality of Life evaluation after surgery
| Study group | Role | What they receive |
|---|---|---|
| Frailty | Experimental | Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools Receives: Other: Frailty and Quality of Life evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after index surgery
Secondary outcomes (16)
1-year mortality
Mortality within 1-year after index surgery
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Postoperative complications
Assessed by validated instruments, Clavien-Dindo Classification
Measured: 30 days after index surgery
Readmissions
Assessed by review of hospital records from the day of discharge after index surgery
Measured: 30 days after index surgery
Length of hospital stay
Assessed by review of hospital records
Measured: 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.
Measured: 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.).
Measured: 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
Measured: At 1 year after index surgery
Time interval to adjuvant chemotherapy
Assessed by review of hospital records.
Measured: 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
Measured: 90 days after index surgery
Health economics
Health economics will be assessed by the Eq5D-5L validated instrument
Measured: 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.
Measured: Up to 60 months after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Mar 2024
- Primary completion28 Mar 2030 (estimated)
- Study completion28 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahar Salehi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahar Salehi, Karolinska University Hospital
- Investigators
- Sahar Salehi, MD, PhD, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298877
- Sponsor's protocol ID
- 2023-04696-01
- Other IDs
- 2023
- Acronym
- FOLERO
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39907536
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06298877
- Acronym / sponsor ID
- FOLERO / 2023-04696-01
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Sahar SalehiUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 28 Mar 2030 (estimated)
- Study completion
- 28 Mar 2031 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frailty | Experimental | Other: Frailty and Quality of Life evaluationSingle arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent
- Age ≥18 years
- Signed written informed consent
Key exclusion criteria (2 listed)
- Not able to understand the Swedish or English language
- Other diagnosis than ovarian cancer on final pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty and Quality of Life evaluationFrailty and Quality of Life evaluation after surgery | Other | Frailty |
Primary outcome
Overall Survival
Time frame: 24 months after index surgery
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.
16 secondary outcomes
1-year mortality
Time frame: 12 months from index surgery
Health related quality of life (HRQoL) (QLQ-C30)
Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (QLQ-OV28)
Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (QLQ-ELD14)
Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Health related quality of life (HRQoL) (EQ-5D-5L)
Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Low anterior resection syndrome (LARS)
Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
Postoperative complications
Time frame: 30 days after index surgery
Readmissions
Time frame: 30 days after index surgery
Length of hospital stay
Time frame: From date of index surgery to the date of discharge or at latest 90 days after index surgery
Extent of surgery vs survival
Time frame: Up to 60 months after index surgery
Sarcopenia vs post-operative outcome
Time frame: Up to 60 months after index surgery
Standard regimen of adjuvant chemotherapy
Time frame: At 1 year after index surgery
Time interval to adjuvant chemotherapy
Time frame: From index surgery to first infusion of adjuvant chemotherapy
Total number of hospital days and readmissions within90 days after index surgery
Time frame: 90 days after index surgery
Health economics
Time frame: At baseline, 12-15 weeks after index surgery and 1 year after index surgery
Recurrence or progression free survival
Time frame: Up to 60 months after index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 39907536Hunde 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahar Salehi, MD, PhD study director
Karolinska University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty and Quality of Life evaluation in people with Ovarian Cancer, run by Sahar Salehi at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fihima M Yusuf, MSc (+46725815883, fihima.mohamed-yusuf@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 24 months after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.