A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Evaluate SAE's associated with TheraSphere® treatment
研究概览
简要总结
Protocol Synopsis Title A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia
Supplier BTG International Canada Inc.
Type of Clinical Use Post-Marketing: TheraSphere® commercially distributed under HDE # 980006
Objectives • Provide supervised access to TheraSphere® therapy at this institution
- Evaluate response to treatment
- Evaluate toxicities and adverse experiences associated with TheraSphere® treatment
- Evaluate survival time
Number of Patients Up to 100 patients per year, expandable following completion of the first cohort.
Patients will be excluded: if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk.
Required Lab Parameters AST or ALT <5 times ULN For HCC: Bilirubin ≤ 2.0 mg/dl (unless segmental infusion is used) Negative pregnancy test in premenopausal women For other primary or secondary liver neoplasia, bilirubin levels specific to the primary or secondary liver neoplasia will be determined to confirm suitability for TheraSphere® treatment Negative pregnancy test in premenopausal women
Endpoints Provide TheraSphere® for patients who it is determined by their treating physicians and/or tumor board that the device is appropriate for the treatment of unresectable HCC in accordance with the FDA recommendation of use of a HUD within its approved indication or for the treatment of the patient's other primary or secondary liver neoplasia and is in accordance with the FDA recommendation of use of a HUD outside of its approved indication.
Evaluate SAE's associated with TheraSphere® treatment.
TheraSphere® Treatment: Suggested Table of Time and Events. TIME Pre-Treatment Evaluation First Treatment First Follow-up Visit Second Treatment3 Post-Treatment Follow-up3 EVENTS -30 to -5 Days Day 0 Day 21 - 42 Day 30 - 90 3 months
- 24 months
详细描述
Introduction
TheraSphere® TheraSphere® consists of insoluble glass microspheres where Y-90 is an integral constituent of the glass. The mean sphere diameter ranges from 20 to 30 µm. Each milligram contains between 22,000 and 73,000 microspheres. TheraSphere® is supplied in 0.6 mL of sterile, pyrogen-free water contained in a 1.0 mL vee-bottom vial secured within a 12 mm clear acrylic vial shield. TheraSphere® is available in six activity sizes: 3 GBq (81 mCi), 5 GBq (135 mCi), 7 GBq (189 mCi), 10 GBq (270 mCi), 15 GBq (405 mCi) and 20 GBq (540 mCi).
TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
Contraindications
Please refer to the current Package Insert. In brief, the use of TheraSphere® is contraindicated in patients:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy.
排除标准
- •Contraindications to angiography and selective visceral catheterization
- •Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment of radiation to the lungs
- •Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
- •Significant extrahepatic disease representing an imminent life-threatening outcome
- •Severe liver dysfunction or pulmonary insufficiency
- •Active uncontrolled infection
- •Significant underlying medical or psychiatric illness
- •Pregnancy
- •Patients will be excluded: if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk.
结局指标
主要结局
Evaluate SAE's associated with TheraSphere® treatment
时间窗: Day 21 after the first treatment till 24 months
life saving measure_ days of survival after the treament
次要结局
未报告次要终点