A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 90
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin 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 radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.
Secondary
- Determine the activity, in terms of clinical response rate and adverse event profile of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy.
- Determine the overall survival, time-to-progression, and time-to-treatment failure for patients receiving the above combined modality treatment.
- Determine the surgical outcome for all patients who undergo esophagectomy.
- Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection.
- Determine quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy.
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 —（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
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
干预措施: carboplatin (Drug)
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
干预措施: Pemetrexed (Drug)
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
干预措施: conventional surgery (Procedure)
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
干预措施: neoadjuvant therapy (Procedure)
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: Baseline to time of surgery (around 10 - 18 weeks post-baseline)
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
次要结局
- Overall Survival(From baseline to 4 years)