Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.
To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status.
Secondary:
Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.
详细描述
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.
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
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
- •2. Patient must recover from the effects of surgery, post-operative infection, or other complications.
- •3. Therapy should start within 5 weeks of surgery
- •4. Must have an estimated survival of \> 8 weeks.
- •5. KPS \< 70.
- •6. Age \> 65 years.
- •7. Must have a pre- and post operative contrast enhanced MRI scans
- •8. Laboratory values within the following limits: ANC (absolute neutrophil count) \>/= 1500 cell/ul Platelets \>/= 100x 10(3)/ul, Hemoglobin \>/= 9g/dl, Serum Creatinine ≤ 1.5mg/dl., Serum total Bilirubin \/= 3g/dl.
排除标准
- •Histology grade less than Anaplastic Glioma ( WHO Grade III).
- •Recurrent malignant glioma.
- •Tumor involving the Brain stem.
- •Any detected tumor foci beyond the cranial vault.
- •Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
- •Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for > 5 years.
- •Prior chemotherapy for the current disease.
研究组 & 干预措施
Cyberknife
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
干预措施: CyberKnife (Procedure)
结局指标
主要结局
Progression Free Survival
时间窗: consent to prgression or death
The Percent Progression -Free Survival at 6 Months Will be Tabulated
时间窗: 6 months
次要结局
- Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.(1year)
研究者
Anand Mahadevan
Radiation Oncologist
Beth Israel Deaconess Medical Center