卵巢癌患者的虚弱、生活质量和暂时性功能障碍造口的早期逆转 (FOLERO)
卵巢癌临时功能障碍造口的虚弱、生活质量和早期逆转 (FOLERO)：一项前瞻性队列研究，旨在确定虚弱对生存的影响并评估临时肠造口的早期逆转
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.
研究概览
详细说明
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)
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Fihima M Yusuf, MSc
- 电话号码：+46725815883
- 邮箱：fihima.mohamed-yusuf@regionstockholm.se
学习地点
-
-
-
Gothenburg、瑞典、41685
- 招聘中
- Sahlgrenska University Hospital and Sahlgrenska Academy
-
接触：
- Pernilla Dahm-Kähler, MD, Prof.
- 电话号码：0313434216
- 邮箱：pernilla.dahm-kahler@gu.se
-
首席研究员：
- Pernilla Dahm-Kähler, MD, Prof.
-
首席研究员：
- Charlotte Palmqvist, MD, PhD
-
Linköping、瑞典、581 85
- 招聘中
- Linköping University Hospital
-
接触：
- Madelene Wedin, MD, PhD
- 邮箱：madelene.wedin@regionostergotland.se
-
首席研究员：
- Madelene Wedin, MD, PhD
-
Lund、瑞典、22185
- 招聘中
- Skåne University Hospital
-
接触：
- Mihaela Asp, MD, PhD
- 邮箱：Mihaela.Asp@skane.se
-
首席研究员：
- Mihaela Asp, MD, PhD
-
副研究员：
- Päivi Kannisto, MD, Ass Prof
-
-
Solna
-
Stockholm、Solna、瑞典、171 76
- 招聘中
- Karolinska University Hospital
-
接触：
- Sahar Salehi, MD, Ass Prof
- 邮箱：sahar.salehi@regionstockholm.se
-
接触：
- Daniel Hunde, MD
- 邮箱：daniel.hunde@regionstockholm.se
-
副研究员：
- Daniel Hunde, MD
-
首席研究员：
- Sahar Salehi, MD, Ass Prof
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
Frailty and Quality of Life evaluation after surgery |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1-year mortality
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：30 days after index surgery
|
Assessed by validated instruments, Clavien-Dindo Classification |
30 days after index surgery
|
|
Readmissions
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
赞助
调查人员
- 研究主任：Sahar Salehi, MD, PhD、Karolinska University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.