NCT02336763终止不适用
Prophylactic Hepatic Irradiation for Uveal Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
This clinical trial studies giving radiation therapy to the liver in patients with uveal (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and therefore more likely to have their disease spread from the eye to the liver. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the liver may reduce the development of tumors in the liver and the overall risk of disease recurrence.
详细描述
PRIMARY OBJECTIVES:
I. Progression free survival in patients treated with prophylactic hepatic irradiation.
SECONDARY OBJECTIVES:
I. Acute and late term toxicity and overall survival.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Histologically confirmed uveal melanoma
- •Monosomy 3 status (by fluorescent in situ hybridization [FISH] or multiplex ligation-dependent probe amplification [MLPA]) or DecisionDx class 2
- •Tumor thickness > 3.0 mm
- •Has received definitive treatment of uveal melanoma with brachytherapy, proton therapy, stereotactic radiosurgery, or enucleation
- •Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG)
- •Total bilirubin < 1.5 mg/dl
- •Aspartate transaminase (AST) up to two times normal limit
- •Alanine transaminase (ALT) up to two times normal limit
- •Creatinine < 2.0 mg/dl
- •Functional left kidney based on computed tomography (CT) imaging
- •Positron emission tomography (PET)/CT demonstrating no evidence of metastatic disease
- •If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use contraception for the duration of radiation therapy (approximately 3 weeks)
- •Understands the trial and procedures and is willing and able to sign the Informed Consent Form
排除标准
- •Previous malignancy, other than localized cutaneous squamous cell carcinoma or basal cell carcinoma
- •History of prior irradiation to the thorax or abdomen
- •Inadequate hepatic or kidney function (as specified above)
- •Active peptic ulcer disease
- •Upper gastrointestinal bleeding
- •Pregnant women or women that refuse to use contraception throughout the entire study period
- •Currently receiving chemotherapy
- •Refuses to sign the informed consent form
结局指标
主要结局
Progression-free Survival
时间窗: Up to 5 years
Reduction in Liver Metastasis
时间窗: Up to 5 years
次要结局
- Disease-specific Survival(Up to 5 years)
- Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4(More than 3 months after study treatment)
- Distant Failure Rates(Up to 5 years)
- Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4(Within 3 months of study treatment)
- Overall Survival(Up to 5 years)
研究者
研究点 (2)
Loading locations...
相似试验
终止
早期 1 期
Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver MetastasesCiliary Body and Choroid Melanoma, Medium/Large SizeCiliary Body and Choroid Melanoma, Small SizeExtraocular Extension MelanomaLiver MetastasesMetastatic Intraocular MelanomaRecurrent Intraocular MelanomaStage IV Intraocular MelanomaIris MelanomaNCT01730157Case Comprehensive Cancer Center6
已完成
2 期
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSFUveal MelanomaLiver MetastasesNCT00661622Sidney Kimmel Cancer Center at Thomas Jefferson University53
已完成
2 期
A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular MelanomaMelanomaNCT00062933National Cancer Institute (NCI)40
进行中（未招募）
2 期
Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver MetastasesMetastatic Malignant Neoplasm in the LiverMetastatic Uveal MelanomaStage IV Choroidal and Ciliary Body Melanoma AJCC V8NCT04728633Thomas Jefferson University28
Unknown
1 期
Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver MetastasesUveal MelanomaHepatic MetastasesNCT02913417David Minor, MD26