Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer
調査の概要
詳細な説明
Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20%. Surgical resection with curative intent remains the most effective treatment for this disease. To improve the survival, a better treatment approach is in need to manage patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies. However, the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results. In fact, treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible.
We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients' survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer. Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes will be compared on an intention-to-treat analysis basis.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Hong Kong、中国
- Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
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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:
- mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable
Exclusion Criteria:
- distant metastasis to solid visceral organs
- local invasion into trachea, descending aorta or recurrent laryngeal nerve.
- patients > 75 years
- serious premorbid condition
- poor physical status that compromised a thoracotomy
- compromised cardiac function
- creatinine clearance less than 50 ml/min were not eligible.
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:ランダム化
- 介入モデル:並列代入
- マスキング:独身
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 |
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全生存
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二次結果の測定
結果測定 |
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1.Disease free survival
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2.Hospital stay
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3.Morbidities
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4.Recurrence of the disease
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協力者と研究者
捜査官
- 主任研究者:Philip WY Chiu, MBChB, FRCSEd、Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
- スタディディレクター:Angus CW Chan, MD、Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
食道がんの臨床試験
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