Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases (Node)
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
調査の概要
詳細な説明
Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV.
Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation.
Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Utrecht、オランダ、3584 CX
- UMC Utrecht
-
-
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:
- Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus.
- Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
- Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
- Age ≥ 18
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent
Exclusion Criteria:
- Distant metastases
- Esophageal carcinoma < 3 cm beneath UES
- Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
- Former radiotherapy or chemotherapy for esophageal carcinoma
- Former radiotherapy precluding radiotherapy according the CROSS protocol
- Inadequate pulmonary function disabling transthoracic resection
- >10% loss of weight in the last six months
- Previous neck dissection
- New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
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：処理
- 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 |
|---|---|
|
他の：surgery
esophagectomy with three-field lymphnode dissection
|
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
|
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 |
|---|---|---|
|
Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
時間枠：5 years
|
Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
|
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
mortality
時間枠：5 years
|
in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
|
5 years
|
|
survival
時間枠：5 years
|
5 year overall- and disease free survival.
|
5 years
|
|
quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
時間枠：10 years
|
QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
|
10 years
|
|
operation related events 1
時間枠：5 years
|
duration of surgery (minutes)
|
5 years
|
|
operation related events 2
時間枠：5 years
|
reason for prolongation of surgery if applicable
|
5 years
|
|
operation related events 3
時間枠：5 years
|
unexpected events/ complications
|
5 years
|
|
operation related events 4
時間枠：5 years
|
bloodloss (ml) reason for conversion if applicable.
|
5 years
|
|
operation related events 5
時間枠：5 years
|
reason for conversion if applicable.
|
5 years
|
|
postoperative recovery
時間枠：5 years
|
duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
|
5 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
pathology results 1
時間枠：5 years
|
pTNM stage
|
5 years
|
|
pathology results 2
時間枠：5 years
|
site of tumour
|
5 years
|
|
pathology results 3
時間枠：5 years
|
length of tumour
|
5 years
|
|
pathology results 4
時間枠：5 years
|
type of tumour
|
5 years
|
|
pathology results 5
時間枠：5 years
|
gradation of tumour
|
5 years
|
|
pathology results 6
時間枠：5 years
|
margins of resection (R0, R1, R2)
|
5 years
|
|
pathology results 7
時間枠：5 years
|
mandard score
|
5 years
|
|
pathology results 8
時間枠：5 years
|
lymphnode status
|
5 years
|
|
pathology results 9
時間枠：5 years
|
vaso-invasion
|
5 years
|
|
pathology results 10
時間枠：5 years
|
perineural growth
|
5 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Richard V Hillegersberg, Prof Dr、UMCU
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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