Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC.
Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial
調査の概要
詳細な説明
Radiotherapy play a critical role in the treatment of head and neck squamous cell carcinoma. Concurrent chemoradiotherapy can increased patients' survival rate. Most of head and neck squamous cell carcinoma patients are in the age range from 60 to 80 years old. Head and neck cancer begin in concealed anatomic sites that make it difficult to found the disease. Therefore, a larger proportion of patients diagnosed with cancer at a late stage.The tissues of head and neck are closely related to important functions such as respiratory, swallowing. Therefore patients are often accompanied by poor nutritional status, cardiac dysfunction and other chronic diseases.Since the tumor is extensive and it cannot be completely resected.These patients are not suitable for surgery alone. Radical radiotherapy or adjuvant radiotherapy is often administered. In order to increase the treatment efficacy, patients with high risk are commonly treated with concurrent chemoradiotherapy. Concurrent chemoradiotherapy often cause serious side effects. For older patients who often have chronic health conditions or poor ECOG(Eastern Cooperative Oncology Group) score are difficult to tolerate.It is crucial to enhance the efficacy of treatment of head and neck squamous cell carcinoma in older patients without causing significant side effect.
Raltitrexed is a direct and specific thymidylate synthase (TS) inhibitor and it is an alternative option for patients unsuitable for cisplatin based chemoradiotherapy. It is more suitable for the treatment of head and neck squamous cell carcinoma in older patients. It is deserved to further investigation. Researches indicated that raltitrexed has shown efficacy and good safety profile in the treatment of colorectal cancer.
It is rarely reported that intensity modulated radiotherapy plus raltitrexed in the treatment of patients with head and neck squamous cell carcinoma,particularly in older patients.The aim of this study was to compare the efficacy of intensity modulated radiotherapy plus raltitrexed with intensity modulated radiotherapy alone in older patients with squamous cell carcinoma of the head and neck.
According to EORTC(European Organization for Research on Treatment of Cancer)22931 study, The 2-year PFS(progression-free survival) was 48% with chemotherapy alone in squamous cell carcinoma of the head and neck. Planting A et al studied raltitrexed at escalating doses combine with radiotherapy in locally advanced head and neck cancer. The results showed that 12 out of 17 patients remained free of locoregional recurrence after a median follow-up of 24(+) months (range 3-60+ months).The study was designed to detect a 15-20% clinic benefit for patients, using α of 0.05 and a β of 0.20. To achieve this, the number of patients required was 101 per group, according to drup-out rate 10%.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Xiupeng Lv, M.D.
- 電話番号：+86-18098876707
- メール：lvxiupeng@foxmail.com
研究場所
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Liaoning
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Dalian、Liaoning、中国、116000
- 募集
- Lv Xiupeng
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コンタクト：
- Xiupeng Lv, M.D.
- 電話番号：18098876707
- メール：lvxiupeng@foxmail.com
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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:
- Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.
- Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.
- Ages≥65 years,Not limited to gender.
- ECOG performance status ≤2.
- Patients with surgical contraindication or reject to surgery.
- Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV, positive surgical margin.
- without evidence of distant metastases.
- No contraindication to chemoradiotherapy.
- Life expectancy > 3 months.
- Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) <1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min
Exclusion Criteria:
- Patients with a history of any other malignancy.
- Concomitant treatment with any other anticancer therapy.
- Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)
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 |
|---|---|
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実験的：Raltitrexed plus Radiation
Raltitrexed 2.5mg/m2, iv, every 3 weeks, concurrently with intensity modulated radiotherapy(IMRT)
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Raltitrexed 2.5mg/m2 on day 1,22,43 during radiotherapy
Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week
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アクティブコンパレータ：Radiation
Intensity modulated radiotherapy(IMRT) alone radical radiotherapy:70Gy/2Gy/7 weeks preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 weeks
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Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week
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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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PFS，Progress Free Survival
時間枠：2 years
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Progress free survival defined as time from the first day of treatment until disease progress or death
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2 years
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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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Incidence of Treatment-Emergent Adverse Events
時間枠：2 years
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Treatment-Emergent Adverse Event is defined according to CTCAE(Common Terminology Criteria for Adverse Events) v.4.0.
All the adverse reactions and serious adverse reactions will be recorded based on laboratory tests, physical examination, ECOG performance status, electrocardiogram and etc.
And then will be graded according to CTCAE v.4.0.
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2 years
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OS，Overall Survival
時間枠：2 years
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Overall survival was defined as time from diagnosis until either death as a result of any cause.
For patients who loss to follow-up before death, defined the last follow-up time as the death time
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2 years
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DCR，Disease Control Rate
時間枠：2 years
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according to RECIST criterion, defined as CR(complete response) + PR(partial reponse) + SD(stable disease)
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2 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LCKY2016-65
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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Raltitrexedの臨床試験
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Centre Hospitalier Universitaire de BesanconHospira, now a wholly owned subsidiary of Pfizer完了