NCT00425841已完成2 期
Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Clinical response rate as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine hydrochloride, and oxaliplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the time to death in patients treated with this regimen.
- Determine perioperative morbidity and mortality in patients treated with this regimen.
- Determine the rate of R0 resections in patients treated with this regimen.
- Determine the histologic response rate in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas or intrapancreatic bile duct carcinoma
- •Overall view of image morphology and CA19-9 (< 500 U/L) demonstrating pancreatic cancer allowed if histologic/cytologic confirmation is unavailable
- •Locally advanced disease, meeting 1 of the following criteria:
- •Uncertain R0 resectability dependant on relation to portal vein, sinus confluens, superior mesenteric artery, and superior mesenteric vein (e.g., contact with portal vein, superior mesenteric vein, or arterial vessels, but < 180° encasement)
- •Unresectable pancreatic cancer (e.g., contact with portal vein, superior mesenteric artery or arterial vessels, > 180° encasement)
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by spiral CT scan or MRI
- •Patients with no measurable disease may be assessed for feasibility only
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
- •WBC ≥ 3,000/mm³
- •Granulocyte count ≥ 2,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine clearance > 30 mL/min
- •Bilirubin ≤ 3.0 times upper limit of normal
- •AST and ALT ≤ 2.5 times normal
- •Alkaline phosphatase ≤ 2.5 times normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No secondary malignancy within the past 5 years that was not curatively treated
- •No known intolerance to any of the study drugs
- •No preexisting polyneuropathy > grade 1
- •No active uncontrolled infection
- •No cardiac insufficiency despite optimal medication
- •No New York Heart Association class III or IV congestive heart failure
- •LVEF ≥ 50% OR shortening fraction ≥ 25%
- •No angina pectoris (at rest or under stress) unexplained by interventional cardiology within the past 6 months
- •No myocardial infarction within the past 6 months
- •No uncontrolled diabetes mellitus
- •No other existing serious medical impairments that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
- •No prior radiotherapy to the abdomen
排除标准
- 未提供
结局指标
主要结局
Clinical response rate as assessed by RECIST criteria
次要结局
- Toxicity as assessed by NCI-CTC criteria
- Time to progression
- Time to death
- Perioperative morbidity and mortality
- Rate of R0 resections
- Histologic response rate
研究者
研究点 (2)
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