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临床试验/NCT00350142
NCT00350142已完成2 期

Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

Albert Koong1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Rate of Local Control

研究概览

简要总结

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

详细描述

In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatic tumors not to exceed 10 cm in greatest axial dimension
  • Histologically confirmed malignancies of the pancreas
  • Unresectable by CT criteria or exploratory laparotomy or laparoscopy
  • Patients with metastatic disease may be treated if they are symptomatic from the primary tumor
  • Performance status of 0, 1, or 2
  • No chemotherapy two weeks prior or two weeks following radiosurgery

排除标准

  • patients who have had prior radiotherapy to upper abdomen
  • patients receiving any prior pancreatic cancer therapy
  • children, pregnant, and breastfeeding women, and lab personnel are excluded
  • uncontrolled intercurrent illnesses
  • any concurrent malignancy

研究组 & 干预措施

Stereotactic Body Radiotherapy

Experimental

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

干预措施: Stereotactic Body Radiotherapy (Radiation)

Stereotactic Body Radiotherapy

Experimental

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

干预措施: Gemcitabine (Drug)

Stereotactic Body Radiotherapy

Experimental

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

干预措施: 4D pancreatic protocol CT scan (Other)

Stereotactic Body Radiotherapy

Experimental

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

干预措施: FDG PET scan (Radiation)

结局指标

主要结局

Rate of Local Control

时间窗: up to 3 years

The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.

次要结局

  • Median Overall Survival Time(up to 3 years)

研究者

发起方
Albert Koong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Albert Koong

Associate Professor of Radiation Oncology

Stanford University

研究点 (1)

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