Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor
A Prospective Randomized Controlled Clinical Study of Albumin-bound Paclitaxel Combined With Cisplatin (AP Regimen) Versus Docetaxel Combined With Cisplatin (TP Regimen) Induced Chemotherapy in Advanced Head and Neck Squamous Tummor
Research Topic:
A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma
Expected study duration:
Each subject received a 3-week regimen of AP or TP over 2 cycles.
Research objectives:
To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared.
Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.
調査の概要
詳細な説明
Research purposes:Research the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma were evaluated,by comparing the AP regimen and the TP regimen .
Research content:To evaluate the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.
Study endpoint Primary endpoint: Objective response rate (ORR=CR+PR) (Assessed according to RECIST standards, see Annex 1) Secondary study endpoint: Surgical resection rate,Pathological remission rate,Progression-free survival (PFS), Overall survival (OS) Main safety indicators: Observe any adverse events that occurred in all subjects during the clinical study and within 1 month after stopping the drug, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory examinations, and record their clinical features, Severity, time of occurrence, duration, treatment method and prognosis outcome, and determine its correlation with the study drug. The safety of the drug was evaluated according to the NCI-CTC AE 4.0 standard.
Study design:This is a single-center, open-label, controlled clinical study.The aime is observing and evaluating the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.
This study is planned to be carried out in Tianjin Cancer Hospital. According to the research principles of GCP.
The study plans to recruit 116 qualified subjects. This study used objective response rate (ORR=CR+PR) as the main evaluation index. According to previous reports, the ORR of the TP group was 50%, and the ORR of the AP group was estimated to be 75%. The test level is set to 0.05 on one side, the test power is set to 0.8, and the estimated dropout rate is 20%. Using the Logrank-Lakatos algorithm, the total sample size is calculated to be 116 cases.
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
研究場所
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Tianjin
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Tianjin、Tianjin、中国、300000
- 募集
- Tianjin Medical University Cancer Institute and 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:
Inclusion criteria:
- Age ≥18 years old, male or female;
- Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology;
- CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th)
- Patients who have not previously received initial treatment with chemotherapy or radiation;
- KPS acuity 70;
- Normal bone marrow reserve function and normal liver and kidney function;
- Expected survival time ≥3 months;
- Subjects of child-bearing age must agree to use effective contraceptive measures during the study period; The serum or urine pregnancy test must be negative for women of childbearing age 72 hours before the start of chemotherapy;
- Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study;
- Subjects voluntarily sign the informed consent.
Exclusion Criteria:
Exclusion criteria:
- Patients with distant metastasis;
- The presence of uncontrolled serious medical diseases, such as combined with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- The presence of dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or filling out questionnaires;
- Subjects with grade ≥2 peripheral neuropathy according to CTCAE V5.0;
- A history of allergy or hypersensitivity to any therapeutic ingredient;
- Suffered from malignant tumors other than squamous cell carcinoma of the head and neck in the past 5 years, except adequately treated basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
Abnormal results of physical and laboratory tests:
A) Hematologic abnormalities are defined as:
I) Absolute count of neutrophils (ANC) : < 1.5×109 / L; Ii) Platelet (PLT) count: < 100×109/L; Iii) Hemoglobin (Hb) level < 90g/L;
B) Abnormal liver function is defined as:
I) Total bilirubin (TBIL) level: 1.5 times of the upper limit of normal value of > (ULN); Ii) AST and ALT levels of >ULN were 2.5 times, and BBB>N was 5 times if liver metastasis was present;
C) Definition of abnormal renal function:
1.5 times of serum creatinine > ULN, or the calculated creatinine clearance rate < 50ml/min;
- Patients who need to be treated with other anti-tumor drugs;
- Has received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
- The researcher considers it unsuitable for inclusion;
- Pregnant or lactating women.
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:トリプル
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:albumin-bound paclitaxel combined with cisplatin (AP regimen)
Paclitaxel (albumin combined type) 260 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; Cisplatin: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles;
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Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
他の名前:
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アクティブコンパレータ:docetaxel combined with cisplatin (TP regimen)
docetaxel: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; cisplatin: 75 mg/m2, d1 every three weeks for a cycle, a total of dosing 2 cycles;
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Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
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 response rate
時間枠:21 days
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ORR=CR+PR
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21 days
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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 |
|---|---|---|
|
OS
時間枠:5年
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全生存
|
5年
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Surgical resection rate
時間枠:1 month
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the rate of Surgical resection in all samples
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1 month
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pathological response rate
時間枠:1 month
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the rate of pathological response in all samples
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1 month
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PFS
時間枠:5 year
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progression-free survival
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5 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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有害事象の発生率
時間枠:90日
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有害事象の発生率
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90日
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協力者と研究者
捜査官
- 主任研究者:Xudong Wang, MD、Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer
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
- TJCIHMF&ENT-001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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