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]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
干预措施: Oxaliplatin (Drug)
Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
干预措施: Radiation (Radiation)
Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
干预措施: Capecitabine (Drug)
Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Month 13
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
时间窗: From Baseline to Month 13
次要结局
- Overall Survival(Cycle 1 Day 1 up to death due to any reason (up to 24 months))
- Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)(Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months))