Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tumor control
研究概览
简要总结
Over the past 15 years, intravenous chemotherapy has become the most popular conservative (eye-saving) method for retinoblastoma treatment because it is often effective and usually safe. In recent years, there has been much interest in providing highly focused (focal) chemotherapy to a diseased organ including the liver, brain, and eye. With focused chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it decreases the chance of toxicity to other organs such as bone marrow suppression (causing low blood counts) and the development of other cancers in the future.
详细描述
The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each individual case. Over the past 15 years, intravenous chemotherapy has risen as the most popular conservative (eye-saving) method for retinoblastoma management because it is effective and safe. In recent years, there has been keen interest in providing chemotherapy more focally to a diseased organ including the liver, brain, and eye. The benefit of focal chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the risk of future cancers.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced retinoblastoma in one or both eyes
- •Recurrent retinoblastoma after failure of previous treatment
- •No age limit (usually kids presenting with retinoblastoma present in the 1st two decades of life)
- •Judged by principal investigator to be medically and physically able to undergo the procedure
排除标准
- •Recurrent retinoblastoma which is treatable with other conservative measures
- •Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for example, into the bone around the eye)
研究组 & 干预措施
Chemotherapy
Chemotherapy using Melphalan, Carboplatin.
干预措施: Melphalan, Carboplatin (Drug)
结局指标
主要结局
Tumor control
时间窗: after 5 cycles of chemotherapy
次要结局
未报告次要终点
研究者
Carol L Shields
Carol L. Shields, MD Co-Director, Ocular Onology Service
Wills Eye