NCT01177007已完成2 期
Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria
研究概览
简要总结
This study is an open label prospective trial of TheraSphere treatment for patients who have liver metastases who have failed or are intolerant to other systemic or liver directed therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then followed for time to progression (TTP), safety, and overall survival.
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
- •18 years of age or older,
- •Patients with a diagnosis of metastatic disease to the liver who have failed or are intolerant to other systemic or liver directed therapies.
- •A patient is considered to have failed to other systemic or liver-directed therapies when, in the opinion of the referring physician, the patient has progression of disease after receiving standard approved therapies. Specifically, if a patient has failed first line chemotherapy (or the standard approved therapies for that particular solid tumor), in the time period designed to assess that particular regimen (at least 30 days), then they may be enrolled into this protocol.
- •A patient is intolerant to other systemic or liver-directed therapies when, in the opinion of the referring physician, for example, the patient is unable to tolerate appropriate chemotherapy, when the patient had residual toxicity from previous therapies (e.g. neuropathy from oxaliplatin), or when the patient's performance status is such that treatment with systemic therapies would result in excessive toxicity.
- •Liver metastases are unresectable
- •Target tumors should be measurable using standard imaging techniques
- •Tumor replacement ≤ 70% of total liver volume based on visual estimation by the Investigator
- •Tumors are hypervascular based on visual estimation by the Investigator
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
- •At least one month has elapsed since most recent prior cancer therapy with the following exceptions
- •Patients who are receiving Sandostatin for treatment of Neuroendocrine cancer may be enrolled and continue their Sandostatin treatment.
- •Patients receiving anti-oestrogen therapy for breast cancer may continue their treatment if therapy was initiated greater than 30 days prior to TheraSphere treatment.
- •Chemotherapy may continue if there is evidence of progression, in the liver, on treatment providing there is no change in the therapy in the 1 month prior to TheraSphere treatment and any immediate chemotherapeutic toxicity that will complicate TheraSphere treatment is resolved. In this case, the chemotherapy may continue because it is continuing to control the extrahepatic disease.
- •Patient is willing to participate in the study and has signed the study informed consent
排除标准
- •At risk of hepatic or renal failure, as indicated by any of the following pre-treatment laboratory and clinical findings within 28 days of treatment:
- •Serum creatinine > 2.0 mg/dL, unless on dialysis
- •Serum total bilirubin ≥ 2.0 mg/dL
- •Albumin < 2.0 g/dL
- •Any history of hepatic encephalopathy
- •Contraindications to angiography and selective visceral catheterization that may include, but are not limited to, the following:
- •Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g., closure device)
- •Severe peripheral vascular disease precluding catheterization
- •History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
- •Severe liver dysfunction or presentation of pulmonary insufficiency or a clinically evident history of chronic obstructive pulmonary disease
- •Cirrhosis or portal hypertension
- •Previous external beam radiation treatment to the liver
- •Any intervention for, or compromise of the Ampulla of Vater
- •Clinically evident ascites. (Note: A radiographic finding of trace ascites on imaging is acceptable).
- •Any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before the first treatment with TheraSphere (if the investigator determines that the continuing complication will compromise the safety of the patient following treatment with TheraSphere).
- •In the judgment of the physician, significant life-threatening extrahepatic disease
- •Concurrent enrollment in another clinical study
- •Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates lung shunting with a potential absorbed dose of radiation to the lungs >30 Gy. The 30 Gy limit is a cumulative limit over all infusions of TheraSphere.
- •Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates a potential for the deposition of microspheres to the gastrointestinal tract that cannot be corrected by placement of the catheter distal to collateral vessels or using standard angiographic techniques, such as coil embolization.
- •A positive serum pregnancy test in women of childbearing potential
- •In the Investigator's judgment, any co-morbid disease or condition or event (e.g., recent myocardial infarction) that would place the patient at undue risk, and that would preclude safe use of TheraSphere
研究组 & 干预措施
TheraSphere
Experimental
干预措施: TheraSphere, Yttrium-90 glass Microspheres (Device)
结局指标
主要结局
Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria
时间窗: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.
This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria
时间窗: 2 years
Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.
次要结局
- Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria(Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.)
- Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0(12 months)
- Tumor Response by the European Association for the Study of the Liver (EASL) Criteria(12 months)
- Overall Survival (OS)(Median follow-up time was 11.41 months (CI: 1.5-33.7))
- Overall Survival (OS) Rate at 2 Years(Up to 2 years)
- Safety as Graded by CTCAE Version 3.0(12 months)
- Mean Radiation Dose Delivered to Total Liver(24 hours)
研究者
Jeff Geschwind
Professor of Radiology and Oncology
Yale University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver CancerUnresectable Hepatocellular CarcinomaNCT01556490Boston Scientific Corporation526
已完成
1 期
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver TumorsCarcinoma, HepatocellularLiver NeoplasmsNCT00493883Southwestern Regional Medical Center81
已完成
3 期
Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver OnlyColorectal NeoplasmSecondary Malignant Neoplasm of LiverNCT00199173Jules Bordet Institute
已完成
2 期
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver MetastasesNeuroendocrine TumorsCholangiocarcinomaBreast CancerMelanomaColorectal NeoplasmsNCT01290536Nicholas Fidelman, MD42
已完成
不适用
Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Unresectable Hepatocellular CarcinomaStage IIIA Hepatocellular Carcinoma AJCC v8NCT01176604M.D. Anderson Cancer Center299