난소암에서 일시적 기능 장애가 있는 장루의 노쇠함, 삶의 질 및 조기 복귀 (FOLERO)
난소암에서 노쇠, 삶의 질 및 일시적 기능 장애 장루의 조기 복귀(FOLERO): 노쇠가 생존에 미치는 영향을 확인하고 임시 장 장루의 조기 복귀를 평가하기 위한 전향적 코호트 연구
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.
연구 개요
상세 설명
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)
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Fihima M Yusuf, MSc
- 전화번호: +46725815883
- 이메일: fihima.mohamed-yusuf@regionstockholm.se
연구 장소
-
-
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Gothenburg, 스웨덴, 41685
- 모병
- Sahlgrenska University Hospital and Sahlgrenska Academy
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연락하다:
- Pernilla Dahm-Kähler, MD, Prof.
- 전화번호: 0313434216
- 이메일: pernilla.dahm-kahler@gu.se
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수석 연구원:
- Pernilla Dahm-Kähler, MD, Prof.
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수석 연구원:
- Charlotte Palmqvist, MD, PhD
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Linköping, 스웨덴, 581 85
- 모병
- Linköping University Hospital
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연락하다:
- Madelene Wedin, MD, PhD
- 이메일: madelene.wedin@regionostergotland.se
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수석 연구원:
- Madelene Wedin, MD, PhD
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Lund, 스웨덴, 22185
- 모병
- Skåne University Hospital
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연락하다:
- Mihaela Asp, MD, PhD
- 이메일: Mihaela.Asp@skane.se
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수석 연구원:
- Mihaela Asp, MD, PhD
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부수사관:
- Päivi Kannisto, MD, Ass Prof
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Solna
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Stockholm, Solna, 스웨덴, 171 76
- 모병
- Karolinska University Hospital
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연락하다:
- Sahar Salehi, MD, Ass Prof
- 이메일: sahar.salehi@regionstockholm.se
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연락하다:
- Daniel Hunde, MD
- 이메일: daniel.hunde@regionstockholm.se
-
부수사관:
- Daniel Hunde, MD
-
수석 연구원:
- Sahar Salehi, MD, Ass Prof
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
Frailty and Quality of Life evaluation after surgery |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: 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. |
24 months after index surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-year mortality
기간: 12 months from index surgery
|
Mortality within 1-year after index surgery |
12 months from index surgery
|
|
Health related quality of life (HRQoL) (QLQ-C30)
기간: 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) |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
|
Health related quality of life (HRQoL) (QLQ-OV28)
기간: 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 |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
|
Health related quality of life (HRQoL) (QLQ-ELD14)
기간: 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) |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
|
Health related quality of life (HRQoL) (EQ-5D-5L)
기간: 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 |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
|
Low anterior resection syndrome (LARS)
기간: At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
Assessed by the validated LARS questionnaire |
At baseline, 12-15 weeks after index surgery and 12 months after index surgery
|
|
Postoperative complications
기간: 30 days after index surgery
|
Assessed by validated instruments, Clavien-Dindo Classification |
30 days after index surgery
|
|
Readmissions
기간: 30 days after index surgery
|
Assessed by review of hospital records from the day of discharge after index surgery |
30 days after index surgery
|
|
Length of hospital stay
기간: From date of index surgery to the date of discharge or at latest 90 days after index surgery
|
Assessed by review of hospital records |
From date of index surgery to the date of discharge or at latest 90 days after index surgery
|
|
Extent of surgery vs survival
기간: 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. |
Up to 60 months after index surgery
|
|
Sarcopenia vs post-operative outcome
기간: 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.). |
Up to 60 months after index surgery
|
|
Standard regimen of adjuvant chemotherapy
기간: 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 |
At 1 year after index surgery
|
|
Time interval to adjuvant chemotherapy
기간: From index surgery to first infusion of adjuvant chemotherapy
|
Assessed by review of hospital records. |
From index surgery to first infusion of adjuvant chemotherapy
|
|
Total number of hospital days and readmissions within90 days after index surgery
기간: 90 days after index surgery
|
Total number of hospital days within 90 days after index surgery by review of hospital records |
90 days after index surgery
|
|
Health economics
기간: 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 |
At baseline, 12-15 weeks after index surgery and 1 year after index surgery
|
|
Recurrence or progression free survival
기간: 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. |
Up to 60 months after index surgery
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Sahar Salehi, MD, PhD, Karolinska University Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2023-04696-01
- 2023 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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