A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer (TOXAG)
2019年10月7日 更新者：Hoffmann-La Roche
Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]
This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer.
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.
研究概览
研究类型
介入性
注册 (实际的)
34
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Adana、火鸡、01250
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
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Ankara、火鸡、06200
- Ankara Oncology Hospital; Oncology
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Ankara、火鸡、06100
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Ankara、火鸡、06490
- Baskent University Medical Faculty; Internal Medicine
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Gaziantep、火鸡、27310
- Gaziantep University Medical Faculty, Medical Oncology Department
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Istanbul、火鸡、34890
- Marmara Uni Faculty of Medicine; Medical Oncology
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Izmir、火鸡、35100
- Ege Uni Medical Faculty; Oncology Dept
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Konya、火鸡、42080
- Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
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Çankaya/Ankara、火鸡、06800
- Bilkent Sehir Hospita; ONKOLOJI
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
- Participants with stages between Stage IB (T1N1M0) and Stage IIIC
- ECOG performance status score equal to or less than (<=) 2 during screening
- Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
- No known contraindication to capecitabine, oxaliplatin, and trastuzumab
- No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason
Exclusion Criteria:
- Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
- Previous neoadjuvant chemotherapy and/or radiotherapy
- Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
- Known (previously diagnosed and ongoing) malabsorption syndrome
- Active gastrointestinal bleeding
- Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
- Clinically significant cardiac or cardiovascular disease
- Uncontrolled hypertension
- Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
- Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
- Known or suspected hypersensitivity against trastuzumab or proteins of rodents
- Pregnancy or lactation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
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Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.
Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.
Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to Month 13
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Baseline up to Month 13
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Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
大体时间：From Baseline to Month 13
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From Baseline to Month 13
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次要结果测量
结果测量 |
大体时间 |
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Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)
大体时间：Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
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Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
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Overall Survival
大体时间：Cycle 1 Day 1 up to death due to any reason (up to 24 months)
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Cycle 1 Day 1 up to death due to any reason (up to 24 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年1月29日
初级完成 (实际的)
2015年8月21日
研究完成 (实际的)
2017年6月15日
研究注册日期
首次提交
2012年12月10日
首先提交符合 QC 标准的
2012年12月12日
首次发布 (估计)
2012年12月13日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年10月7日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Oxaliplatin的临床试验
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Hospices Civils de Lyon未知