Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)
2017年8月26日 更新者:Sung-Bae Kim、Asan Medical Center
A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.
調査の概要
詳細な説明
After completion of concurrent chemoradiotherapy, patients will be reassed and visited to multidisciplinary clinic, then, randomized to either observation or esophagectomy.
研究の種類
介入
入学 (予想される)
486
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Seoul、大韓民国、05505
- Asan Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the intrathoracic esophagus
- Surgically resectable (cT3, cT4a and/or disease with lymph node metastasis by AJCC 7th ed) esophageal cancer, as determined by Endoscopic Ultra Sound (EUS), chest CT and PET-CT
- No prior treatment for the esophageal cancer
- Age: 20-70 years
- ECOG performance status 0, 1 or 2
- Adequate hematological, renal, hepatic, pulmonary and cardiac functions defined as 6.1 Granulocytes > 1,500/microliter, Platelets > 75,000/microliter 6.2 Creatinine < 1.5 mg/dL (or CCr> 50 mg/mL), 6.3 Total bilirubin < 1.5 mg/dL 6.4 ALT and AST < 2.5 × upper normal limit 6.5 FEV1 >=1.5 L/min 6.6 Ejection fraction >= 45%
- Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
- Written, voluntary informed consent
Exclusion Criteria:
- Subtypes other than squamous cell carcinoma
- cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
- Invasion of recurrent laryngeal, phrenic or sympathetic nerve
- Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
- Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
- Malignant pleural effusion (documented by cytospin or cytology)
- Cervical esophageal cancer
- Para-aortic lymph node metastasis
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, curatively treated carcinoma in situ of the cervix, curatively treated early gastric cancer with endoscopic mucosal resection or a cured malignancy more than 5 years prior to enrollment
- Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
- Patients with a known history of HIV seropositivity or HCV (+). Patients with HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Other serious illness or medical conditions A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection (viral, bacterial or fungal infection) D. Other serious medical illnesses
- New York heart Association Class III/IV and history of active angina. Documented myocardial infarction within the 6 months preceding registration. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks.
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Uncontrolled diabetes mellitus: fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control; fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
|
介入なし:Arm B: observation:
No additional treatment after concurrent chemoradiotherapy.
However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
|
|
|
実験的:Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
|
食道切除術
|
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 |
時間枠 |
|---|---|
|
2-year disease-free survival (DFS) rate
時間枠:2 years from the enrollment of last patient
|
2 years from the enrollment of last patient
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall survival (OS)
時間枠:5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
progression-free survival
時間枠:5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
failure pattern
時間枠:5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
Number of Participants with Adverse Events
時間枠:up to 60 days after treatment
|
up to 60 days after treatment
|
|
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
時間枠:5 years
|
5 years
|
|
Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of OS according to metabolic response after induction chemotherapy
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Quality of life
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of PFS according to metabolic response after induction chemotherapy
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to metabolic response after induction chemotherapy
時間枠:5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
treatment-related mortality
時間枠:up to 60 days after completion of treatment
|
up to 60 days after completion of treatment
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年11月1日
一次修了 (実際)
2017年1月1日
研究の完了 (実際)
2017年1月1日
試験登録日
最初に提出
2012年11月27日
QC基準を満たした最初の提出物
2012年11月30日
最初の投稿 (見積もり)
2012年12月4日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月29日
QC基準を満たした最後の更新が送信されました
2017年8月26日
最終確認日
2017年8月1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。
食道扁平上皮がんの臨床試験
-
Taichung Veterans General Hospital完了心毒性 | 非小細胞肺癌(MeSH用語:Carcinoma, Non-Small-Cell Lung) | 薬物関連の副作用および有害反応(MeSH用語) | EGFRチロシンキナーゼ阻害剤台湾
-
Fondazione del Piemonte per l'Oncologia募集乳がん | 卵巣がん | 結腸直腸がん | 黒色腫 (皮膚がん) | 非小細胞肺癌(MeSH用語:Carcinoma, Non-Small-Cell Lung)イタリア