A Randomized Prospective Two Arm Clinical Trial of High Light Dose And Low Light Dose PDT in the Treatment of Recurrent Malignant Supratentorial Gliomas Using Porfimer Sodium [Photofrin]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Time to progression and survival measured
研究概览
简要总结
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic therapy using porfimer sodium to compare how well they work in treating patients who are undergoing surgery for recurrent malignant astrocytoma.
详细描述
OBJECTIVES:
- Compare survival of patients undergoing surgical resection for recurrent high-grade malignant supratentorial astrocytoma treated with intraoperative high vs low light dose photodynamic therapy using porfimer sodium.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
- Arm I: During surgery, patients receive low light dose photodynamic therapy.
- Arm II: During surgery, patients receive high light dose photodynamic therapy. After completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months and then every 3 months for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
干预措施: porfimer sodium (Drug)
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
干预措施: adjuvant therapy (Procedure)
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
干预措施: conventional surgery (Procedure)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
干预措施: porfimer sodium (Drug)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
干预措施: adjuvant therapy (Procedure)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Time to progression and survival measured
时间窗: at 4-6 weeks post-operatively and then every 3-4 months thereafter
次要结局
未报告次要终点