A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Overall survival at 12 months after radiation therapy
研究概览
简要总结
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
详细描述
Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.
In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.
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
- •Biopsy proven unresectable adenocarcinoma of the pancreas.
- •Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
- •A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
- •Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
- •Required pretreatment laboratory parameters:
- •Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
- •Platelet count ≥ 100,000/mm3
- •Bilirubin < 2 mg/dl
- •ALT/SGPT < 3x upper limit of normal
- •Creatinine < 3 mg/dl
排除标准
- •Evidence of distant metastasis.
- •Prior surgical resection.
- •Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
- •Active or untreated infection,
- •Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
- •Previous Radiation to the abdomen.
研究组 & 干预措施
Proton Radiation with capecitabine
The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
干预措施: Proton Radiation (Radiation)
Proton Radiation with capecitabine
The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
干预措施: Capecitabine (Drug)
Proton Radiation with capecitabine
The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
干预措施: Surgical resection (Procedure)
结局指标
主要结局
Overall survival at 12 months after radiation therapy
时间窗: Approximately 12 months after radiation therapy.
The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.
次要结局
- Surgical resection rate.(3 months following the completion of radiation therapy.)