Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)
A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
調査の概要
状態
条件
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
研究場所
-
-
Shanxi
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Xi'an、Shanxi、中国、710032
- 積極的、募集していない
- Xijing Hospital, GI institute
-
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Sichuan
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Chengdu、Sichuan、中国、610000
- 募集
- friendship Hospital
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コンタクト：
- lili deng, MD
- 電話番号：+8613880926676
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Siyang、Sichuan、中国
- 募集
- Ziyang People's Hospital
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コンタクト：
- min wei, MD
- 電話番号：+8613980386078
-
-
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:
- Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
- EUS or MRI stage T3-4, any N, M0.
- Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
- Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
- No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
- Patients must have a life expectancy of at least 16 weeks.
- Performance status of < 2 (Zubrod scale).
- No biopsy proof of lymph node metastases outside the study field.
- No evidence of metastatic disease to distant organs.
- No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
- No uncontrolled or severe cardiac disease, diabetes or hypertension.
- Signed study-specific consent form prior to study entry.
Exclusion Criteria:
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
- Cardiac failure or Sever Pulmonary disease
- Patients with impaired gastrointestinal absorption for whatever reason
- Patients medically unfit for cisplatin or taxol 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1 pre-operative chemoradiation
Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
|
Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29. |
|
アクティブコンパレータ：Arm 2 post operative chemoradiation
Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2
|
Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29 |
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 |
|---|---|
|
Progression Free Survival
時間枠：up to 5 year
|
up to 5 year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall Survival
時間枠：up to 5 year
|
up to 5 year
|
|
R0 Resection Rate
時間枠：At time of surgery
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At time of surgery
|
協力者と研究者
協力者
捜査官
- スタディチェア：Ming Zeng, MD PhD、Sichuan Academy of Medical Science
- スタディチェア：Hongwei Zhang, MD PhD、Xijing Hosptial, GI institute
研究記録日
主要日程の研究
研究開始
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。
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