TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 10
- 主要终点
- Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
研究概览
简要总结
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18 years of age or older
- •diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
- •unresectable liver metastases
- •target tumors measurable using standard imaging techniques
- •tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
- •Hypervascular tumors (visual estimation by investigator)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
- •patient informed consent
排除标准
- •At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
- •contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
- •severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
- •cirrhosis or portal hypertension
- •prior external beam radiation treatment to the liver
- •prior TheraSphere treatment to the liver
- •any intervention for, or compromise of the Ampulla of Vater
- •clinically evident ascites (trace ascites on imaging is acceptable)
- •any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
- •significant life-threatening extrahepatic disease in judgment of physician
- •concurrent enrollment in another study
- •alternative available therapies in judgement of physician
- •evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit
- •evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
- •positive serum pregnancy test in women of childbearing potential
- •co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
结局指标
主要结局
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
时间窗: From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
次要结局
- Overall Survival(Time from first TheraSphere treatment to death; median follow up 30 months)