Study of Split-course Chemoradiotherapy For Postoperative Locoregional Recurrence Of Non-small Cell Lung Cancer
2021年1月15日 更新者：Hui Liu、Sun Yat-sen University
A Prospective, Randomized, Phase Ⅱ Study of Split-course Chemoradiotherapy For Locoregional Recurrence Of Non-small Cell Lung Cancer After Surgical Resection
This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection
調査の概要
詳細な説明
This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection.
Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
研究の種類
介入
入学 (予想される)
57
段階
- フェーズ2
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
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Guangdong
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Guangzhou、Guangdong、中国、510000
- 募集
- Hui Liu
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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
18年～75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:
- Pathologic confirmation of NSCLC.
- Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Previously treated with chemotherapy or treatment-naive
- No previous chest radiotherapy, immunotherapy or biotherapy
- Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- Forced expiratory volume at one second (FEV1) >0.8 L
- Coagulation tests within normal limits
- patients and their family signed the informed consents
Exclusion Criteria:
- Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- Second primary carcinoma of the lung
- Contraindication for chemotherapy
- Malignant pleural or pericardial effusion.
- Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos
- Women who has the probability of pregnancy without contraception
- Tendency of hemorrhage
- In other clinical trials within 30 days
- Addicted in drugs or alcohol, AIDS patients
- Uncontrollable seizure or psychotic patients without self-control ability
- Severe allergy or idiosyncrasy
- Not suitable for this study judged by researchers
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：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 |
|---|---|
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実験的：split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT.
Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV.
The disease is re-evaluated one month after the end of the initial course using CT.
The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost.
At the second course, the tumor is repositioned and scanned.
The residual tumor was then treated with the second course of radiotherapy.
A dose of 15-24 Gy/5-8f is delivered to the residue tumor.
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
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毎週ドセタキセル（25mg/㎡）とネダプラチン（25mg/㎡）を胸部放射線療法と併用
split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
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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 |
時間枠 |
|---|---|
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無増悪生存
時間枠：2年
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2年
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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全生存
時間枠：2年
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2年
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回答率
時間枠：2年
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2年
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rate of patients who develop local recurrence or distant recurrence
時間枠：2 year
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2 year
|
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rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0
時間枠：1 year
|
1 year
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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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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 (実際)
2015年8月1日
一次修了 (実際)
2020年6月1日
研究の完了 (予想される)
2021年7月1日
試験登録日
最初に提出
2016年4月13日
QC基準を満たした最初の提出物
2016年12月28日
最初の投稿 (見積もり)
2016年12月30日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月20日
QC基準を満たした最後の更新が送信されました
2021年1月15日
最終確認日
2021年1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。
非小細胞肺がんの臨床試験
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