A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Determine Pathologic Complete Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.
Secondary
- Determine the clinical response rate in patients treated with this regimen.
- Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
- Characterize the toxicity profile of this regimen in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Induction Therapy - Capecitabine (Drug)
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Combination Therapy - Radiation (Radiation)
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Induction Therapy - Oxaliplatin (Drug)
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Combination Therapy - Capecitabine (Drug)
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Combination Therapy - Oxaliplatin (Drug)
Induction, Combination and surgery
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
干预措施: Evaluation for response and surgery (Procedure)
结局指标
主要结局
Determine Pathologic Complete Response
时间窗: At time of surgery
Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
次要结局
- Patterns of Failure(At time of surgery)
- Toxicity Profile(During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.)
- Clinical Response Rate(four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery)
- Recurrence Rate(From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.)
- Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.(At time of sugery)
- Time to Progression(From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.)