Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer (CAPITAL)
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.
Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
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
研究場所
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Guangdong
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Chaozhou、Guangdong、中国
- the central hospital of Chaozhou
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Foshan、Guangdong、中国
- The 1st People's Hospital of Foshan
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Guangzhou、Guangdong、中国
- Cancer center of Sun Yat-sen University
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Guangzhou、Guangdong、中国
- cancer center of Guangzhou medical college
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Guangzhou、Guangdong、中国
- Guangdong Traditional Medical Hospital
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Guangzhou、Guangdong、中国
- the 1st affliated hospital of Guangdong pharmacuetic college
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Guangzhou、Guangdong、中国
- the 1St Affliated Hospital of Guangzhou Medical College
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Guangzhou、Guangdong、中国
- the 6th affliated hospital of Sun-yat-sen University
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Shantou、Guangdong、中国
- the 1st hospital of Shantou University
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Shantou、Guangdong、中国
- the cental hospital of Shantou
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Shaoguan、Guangdong、中国
- YUE-BEI people's hospital
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Shenzhen、Guangdong、中国
- The 2nd People's Hospital of Shenzhen
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Zhuhai、Guangdong、中国
- the 5th hospital of Sun-yat-sen University
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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:
- informed consensus of patients
- be able to receive oral administration
- from 18 to 70 years old
- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
- normal function of other organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status:0~2
Exclusion Criteria:
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators
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：S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
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6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
他の名前：
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アクティブコンパレータ：S-1 single
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
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16 courses S-1 single after d D2 resection
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 |
時間枠 |
|---|---|
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全生存
時間枠：5年
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5年
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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無病生存
時間枠：3年
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3年
|
|
有害事象のある参加者の数
時間枠：5年
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5年
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Zhiwei Zhou, PHD、SunYat-sen University
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 (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
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