NCT00003788Unknown3 期
Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
Colorado Health Foundation8 个研究点 分布在 2 个国家目标入组 270 人开始时间: 1998年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 270
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.
PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
详细描述
OBJECTIVES:
- Determine whether the addition of photodynamic therapy to standard brain tumor care (surgical resection, postoperative radiotherapy, and chemotherapy) will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas.
- Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas.
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
- Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma
- •Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification
- •Suitable for radical resection on the basis of imaging studies
- •Patients with recurrent disease must have failed surgery and radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100% for newly diagnosed tumor
- •Karnofsky 70-100% for recurrent tumor
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Recurrent tumor:
- •WBC at least 2,000/mm^3
- •Platelet count at least 80,000/mm^3
- •Recurrent tumor:
- •PT/PTT no greater than 1.5 times upper limit of normal (ULN)
- •Bilirubin and LFTs less than 2 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •GGT no greater than 3 times ULN
- •Creatinine no greater than 2 mg/dL
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior cranial radiotherapy for newly diagnosed tumor
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (8)
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