A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Maximum Tolerated Radiation Dose
研究概览
简要总结
This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.
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
- •Is the patient 18 years of age or older.
- •Does the patient have histologically or cytologically proven carcinoma of the pancreas
- •Is the tumor unresectable or medically inoperable
- •Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
- •Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
- •Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
- •Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
- •If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
- •Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent
排除标准
- •Does the patient have a neuroendocrine tumor of the pancreas
- •Does the patient have metastatic disease
- •Does the patient have a history of abdominal radiation therapy
- •Is there history of more than 1 month of therapy with single agent gemcitabine
- •Has the patient used any investigational agent in the month before enrollment into the study
研究组 & 干预措施
Radiation Dose Escalation with Gemcitabine
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
- BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
干预措施: INTENSITY MODULATED RADIOTHERAPY (Radiation)
Radiation Dose Escalation with Gemcitabine
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
- BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
干预措施: Gemcitabine (Drug)
结局指标
主要结局
The Maximum Tolerated Radiation Dose
时间窗: 13 weeks post radiation
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
次要结局
- The Percentage of Participants Free From Local Progression at 2 Years(2 Years)