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NCT Number: NCT06298877

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, Stockholm, Solna, Sweden

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty and Quality of Life evaluation

Other

Frailty and Quality of Life evaluation after surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 1-year mortality

    Time frame: 12 months from index surgery

    Mortality within 1-year after index surgery

  2. Health related quality of life (HRQoL) (QLQ-C30)

    Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

    Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), Core Questionnaire (QLQ-C30)

  3. Health related quality of life (HRQoL) (QLQ-OV28)

    Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

    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

  4. Health related quality of life (HRQoL) (QLQ-ELD14)

    Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

    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)

  5. 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

    Assessed by validated questionnaire and comprise the European Organisation for Research and Treatment of Cancer (EORTC), EQ-5D-5L

  6. Low anterior resection syndrome (LARS)

    Time frame: At baseline, 12-15 weeks after index surgery and 12 months after index surgery

    Assessed by the validated LARS questionnaire

  7. Postoperative complications

    Time frame: 30 days after index surgery

    Assessed by validated instruments, Clavien-Dindo Classification

  8. Readmissions

    Time frame: 30 days after index surgery

    Assessed by review of hospital records from the day of discharge after index surgery

  9. Length of hospital stay

    Time frame: From date of index surgery to the date of discharge or at latest 90 days after index surgery

    Assessed by review of hospital records

  10. Extent of surgery vs survival

    Time frame: Up to 60 months after index surgery

    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.

  11. Sarcopenia vs post-operative outcome

    Time frame: Up to 60 months after index surgery

    Sarcopenia is measured by computed tomography and different muscle groups by different software programs (e.g. Coreslicer, Slice-o-matic etc.).

  12. Standard regimen of adjuvant chemotherapy

    Time frame: At 1 year after index surgery

    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

  13. Time interval to adjuvant chemotherapy

    Time frame: From index surgery to first infusion of adjuvant chemotherapy

    Assessed by review of hospital records.

  14. Total number of hospital days and readmissions within90 days after index surgery

    Time frame: 90 days after index surgery

    Total number of hospital days within 90 days after index surgery by review of hospital records

  15. Health economics

    Time frame: At baseline, 12-15 weeks after index surgery and 1 year after index surgery

    Health economics will be assessed by the Eq5D-5L validated instrument

  16. Recurrence or progression free survival

    Time frame: Up to 60 months after index surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fihima M Yusuf, MSc

CONTACT

[email protected]

+46725815883

Sponsors and collaborators

Lead sponsor

Sahar Salehi

Other

Registry information

Official study 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

Acronym: FOLERO

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 7, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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