Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study
Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study
調査の概要
詳細な説明
There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Miaoli
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Zhunan、Miaoli、台湾、350
- National Health Research Institutes
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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:
- Pathologically confirmed gastric adenocarcinoma.
- At least one measurable lesion in a non-irradiated area.
- No prior exposure to systemic chemotherapy for advanced gastric cancer.
- For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
- Age > 20 years old.
- ECOG Performance Status 2.
- Life expectancy greater than 12 weeks.
- Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
- Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
- Adequate renal function :Creatinine < 1.5 x ULN.
- Patients must be accessible for treatment and follow-up in the participating centers.
Exclusion Criteria:
- Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
- Major surgery within two weeks prior to entering the study.
- Patients with CNS metastasis, including clinical suspicion.
- Patients who are under active or uncontrolled infections.
- Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
- Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
- Patients with concomitant illness that might be aggravated by chemotherapy.
- Patients who are pregnant or with breast feeding.
- Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
- Patients with hypersensitivity to any component of the chemotherapeutic regimen.
- Mental status is not fit for clinical trial
- Can not take study medication orally
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
- 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：chemotherapy
Chemotherapy: Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy. |
Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial. Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.
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：Every 6 weeks
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Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group .
The new version 1.1 was published in 2009.
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Every 6 weeks
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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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Progression-free survival
時間枠：Every 6 weeks
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Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).
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Every 6 weeks
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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
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- T3211
- 100CT202 (その他の助成金/資金番号：NRPB)
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。
Capecitabine, Oxaliplatin, Docetaxelの臨床試験
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Hospices Civils de Lyonわからない