To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.
2018年2月28日 更新者：Shen Lin、Peking University
A Retrospective Cohort Study
To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib
調査の概要
詳細な説明
Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy.
Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of <0.05 was considered statistically significant.
研究の種類
観察的
入学 (予想される)
60
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing
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Beijing、Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
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コンタクト：
- Jian Li, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Test group is imatinib 400 mg/day or higher dose treatment failure and satisfactory reduction of tumor surgery patients with advanced gastrointestinal stromal tumor, patients must meet all the inclusion criteria and exclusion criteria to enter test.
説明
Inclusion Criteria:
- .Histopathological diagnosis of metastatic GIST.
- . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
- . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
- at least 1 month after surgery for imatinib treatment or sunitinib treatment.
- at least one imaging assessment was received after surgery.
- . Complete clinical data and follow-up data.
Exclusion Criteria:
- . Before operation, he was treated with sunitinib
- . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
- . The treatment of imatinib or sunitinib after surgery was less than 1 month.
- . Incomplete clinical data or follow-up data.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Arm A
Imatinib 400 mg/day or 600mg/day, and within 6 weeks after surgery, continuous treatment was not tolerated until tumor progression, recurrence or adverse reactions were not tolerated.
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exposure 400 mg/day or 600mg/day,
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Arm B
Sunitinib 37.5 mg/day, continuous taking, or 50 mg/day (4/2), began within 6 weeks after surgery, and was continuously administered until tumor progression, recurrence or adverse reactions were not tolerated
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exposure 37.5 mg/day, continuous taking, or 50 mg/day (4/2)
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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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Efficiency
時間枠：12 months
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The curative effect was evaluated by measuring the unprogression-survival (PFS) each treatment group.
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12 months
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Security
時間枠：12 months
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Clinical and laboratory toxicity/symptoms will be graded according to the nci-ctc toxicity criteria.
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12 months
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Molecular marker detection
時間枠：12 months
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Gene mutation of c-kit/PDGFRA of imatinib resistance
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年6月2日
一次修了 (予想される)
2018年6月2日
研究の完了 (予想される)
2018年8月8日
試験登録日
最初に提出
2018年1月3日
QC基準を満たした最初の提出物
2018年1月31日
最初の投稿 (実際)
2018年2月7日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月1日
QC基準を満たした最後の更新が送信されました
2018年2月28日
最終確認日
2018年2月1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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