Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer
調査の概要
詳細な説明
Esophageal cancer (EC) continues to be a major health burden worldwide. The 5-year survival rates for esophageal cancer have remained less than 15% over decades, probably because of ineffective therapies and the detection of late-stage cancers. Concurrent chemo-radiotherapy was established as one of the viable options for therapy of patients with localized EC following the results from the landmark trial of the Radiation Therapy Oncology Group (RTOG) 85-01 trial, showing a significant survival advantage of concurrent chemoradiation over radiation alone.
The use of radiochemotherapy with cisplatin and 5-fluorouracil (5-FU) is a well-accepted standard for the definitive treatment of esophageal cancer in China which has also been demonstrated efficacy and good tolerability internationally. The AJCC recommended dose range of radiotherapy for concurrent therapy is 45-50.4Gy. Moreover, (RTOG) 85-01 trial also established 50.4 Gy as the standard dose of radiation to be administered concurrently with chemotherapy. However, the appropriate dose of radiation fit for Chinese remains controversial. Due to insufficient evidence of EBM, radiation therapist in China always prescribe a radiation dosage by their own experience. Dosages (e.g. 60-64Gy) significantly higher than the international standard is commonly used in Chinese EC patients which lead to a greater likelihood of toxicity. Thus Chinese oncologists are urgent to reach a consensus about radiation dosage in the standard treatment of local advanced EC.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210029
- Jiangsu Province Hospital
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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:
- Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction
- Measurable lesion
- Age > 18 years
- Karnofsky performance score > 70
- Life expectancy > 3 months
- Adequate bone marrow function (white blood cell [WBC] count ≥ 3.5 109/L, neutrophil count ≥ 2.0 109/L, and platelet count ≥ 100 109/L), adequate renal function (creatinine ≤ 2 mg/dL or creatinine clearance ≥ 50 mL/min), and normal liver function (aspartate aminotransferase and alanine aminotransferase less than two times the upper limit of normal, total serum bilirubin ≤ 1.5 mg/dL).
Exclusion Criteria:
- Prior systemic chemotherapy for EC
- Evidence of distant metastatic disease
- Evidence of uncontrolled medical conditions (e.g.,serious infection,grade 4 hypertension,congestive heart failure)
- A history of concomitant or previous malignancy.
- Physical evidence of peripheral neuropathy or hearing loss
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Concurrent radiochemotherapy
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initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f
cisplatin 75 mg/m2 on day 1 with standard hydration fluorouracil 1000 mg/m2/day1 i.v. by continuous infusion from day 1 to day 4 of each cycle
他の名前：
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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 |
|---|---|---|
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Objective Tumor Response
時間枠：One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
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objective evaluation is made according to the standards of Response Evaluation Criteria in Solid Tumors (RECIST)，defined as complete response(CR),partial response (PR)，stable disease(SD),and progressive disease (PD).Tumor sizes are measured using barium esophagram or CT.
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One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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adverse events
時間枠：Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks
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using the National Cancer Institute Common Toxicity Criteria,predominantly observe the presence of radiation esophagitis,radiaion pneumonia and hematological toxicity.
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Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks
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協力者と研究者
捜査官
- 主任研究者：Xinchen Sun, M.D.,Ph.D.、The First Affiliated Hospital with Nanjing Medical University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
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