A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
研究概览
简要总结
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.
详细描述
Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Three dose levels are planned, as shown in the "Dose Escalation" table below. Three patients are planned at each level. When 3 patients have completed an entire chemoradiation course and are monitored for at least 2 weeks after the end of treatment without the occurrence of dose limiting toxicities (DLTs), then the next 3 patients will be treated at the next highest dose level. If one of the first three patients treated at any given dose level experiences a DLT, three further patients will be treated at that level. If only one in six patients at a given level experiences a DLT, escalation can proceed. If two or more of three to six patients at the lowest administered dose level experience DLTs, then the MTD is below the lowest administered dose, but no specific MTD will be defined. If two or more of three to six patients at a higher dose level experiences DLTs, the dose preceding the lowest dose level satisfying this criterion will be declared the MTD. If all the dose levels are exhausted without two or more of three to six patients experiencing DLTs, then the MTD is higher than the maximum administered dose, but no specific MTD will be defined. If MTD is reached at a given dose level, then additional patients can be accrued to the next lowest dose level, such that up to six patients can be accrued to the dose level below MTD. Because three dose levels are planned, with 3 to 6 patients enrolled in each dose level, a minimum of 9 and a maximum of 18 patients are required for trial completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
All patients
All participants enrolled.
干预措施: Radiation Therapy (Radiation)
All patients
All participants enrolled.
干预措施: Capecitabine (Drug)
All patients
All participants enrolled.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
时间窗: September 2012
次要结局
- To determine tumor response rate, survival rate, local control rate and rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.(September 2012)