IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma
Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.
Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
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:
- The sex of the subject is not limited, the age is from 18 to 70 years old;
- Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
- Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
- Karnofsky score ≥ 80 points;
- No evidence of distant metastasis;
- Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.
Exclusion Criteria:
- The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
- Previously received immunotherapy;
- Previously received chemotherapy;
- Previously received radiation therapy;
- Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
- Evidence of distant metastases or other malignancies at the same time.
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：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 |
|---|---|
|
実験的：IMRT group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
|
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
他の名前：
|
|
他の：IMRT plus cisplatin group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
|
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
他の名前：
Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
|
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 |
|---|---|---|
|
Overall survival rate
時間枠：up to 3 years
|
Refers to the time from included to death due to any cause.
|
up to 3 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (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 (実際)
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
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。
上咽頭がんの臨床試験
-
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
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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
Intensity modulated radiotherapyの臨床試験
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University of Texas Southwestern Medical Center募集
-
Gisela Grotewold Chelimsky終了しました
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Ming-Yuan Chen募集