虚弱、生活の質、および卵巣がんにおける一時的機能不全ストーマの早期回復 (FOLERO)
虚弱、生活の質、および卵巣がんにおける一時的機能不全ストーマの早期回復 (FOLERO) : フレイルが生存に及ぼす影響を判定し、一時的腸ストーマの早期回復を評価するための前向きコホート研究
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.
調査の概要
詳細な説明
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)
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Fihima M Yusuf, MSc
- 電話番号：+46725815883
- メール：fihima.mohamed-yusuf@regionstockholm.se
研究場所
-
-
-
Gothenburg、スウェーデン、41685
- 募集
- Sahlgrenska University Hospital and Sahlgrenska Academy
-
コンタクト：
- Pernilla Dahm-Kähler, MD, Prof.
- 電話番号：0313434216
- メール：pernilla.dahm-kahler@gu.se
-
主任研究者：
- Pernilla Dahm-Kähler, MD, Prof.
-
主任研究者：
- Charlotte Palmqvist, MD, PhD
-
Linköping、スウェーデン、581 85
- 募集
- Linköping University Hospital
-
コンタクト：
- Madelene Wedin, MD, PhD
- メール：madelene.wedin@regionostergotland.se
-
主任研究者：
- Madelene Wedin, MD, PhD
-
Lund、スウェーデン、22185
- 募集
- Skåne University Hospital
-
コンタクト：
- Mihaela Asp, MD, PhD
- メール：Mihaela.Asp@skane.se
-
主任研究者：
- Mihaela Asp, MD, PhD
-
副調査官：
- Päivi Kannisto, MD, Ass Prof
-
-
Solna
-
Stockholm、Solna、スウェーデン、171 76
- 募集
- Karolinska University Hospital
-
コンタクト：
- Sahar Salehi, MD, Ass Prof
- メール：sahar.salehi@regionstockholm.se
-
コンタクト：
- Daniel Hunde, MD
- メール：daniel.hunde@regionstockholm.se
-
副調査官：
- Daniel Hunde, MD
-
主任研究者：
- Sahar Salehi, MD, Ass Prof
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools |
Frailty and Quality of Life evaluation after surgery |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1-year mortality
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：30 days after index surgery
|
Assessed by validated instruments, Clavien-Dindo Classification |
30 days after index surgery
|
|
Readmissions
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Sahar Salehi, MD, PhD、Karolinska University Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。