NCT04933435招募中不适用
Phase II Non-Randomized Trial of Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
研究概览
简要总结
This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI
- •Patient is 18 years or older
- •ECOG Performance status of 0-2
- •Child Pugh score A5, A6, B7 or B8 (see Appendix)
- •Lesion ≤ 5cm in size
- •≤ 3 lesions in the liver to be treated on protocol
- •Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
排除标准
- •Child Pugh score B9 or Class C
- •Fluctuating ascites
- •Inability to complete baseline Quality of Life survey forms
- •Concurrent administration of systemic therapy for hepatocellular carcinoma
- •Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
结局指标
主要结局
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
时间窗: baseline, 1 month, 3 months, 6 months
as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse)
次要结局
- total healthcare system cost associated with Hypofractionated Liver Directed Therapy(90 days)
- number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy(90 days)
- total healthcare system cost associated with Interventional Radiology Liver Directed Therapies(90 days)
- change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT(baseline, 1 month, 3 months, 6 months)
- number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy(90 days)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
2 期
Health-related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using Traditional Chinese Medicine: The HERBAL TrialFatigueCognitive ImpairmentCancerNCT04104113National University of Singapore80
进行中（未招募）
不适用
Clinical trial in patients with metastatic colorectal Cancer to evaluate the response of removable liver metastases after treatment with Cetuximab (Erbitux).EUCTR2013-002347-28-ESACROSS: Associació Catalana per a la Recerca Oncològica i les seves implicacions sanitàries i Socials
已完成
4 期
An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic OsteoarthritisOsteoarthritisNCT01728246Janssen Pharmaceutica473
已完成
不适用
Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor TherapyBreast NeoplasmsNCT00784888Pfizer344
进行中（未招募）
1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)Salivary gland cancerMedDRA version: 20.0Level: PTClassification code 10061497Term: Salivary gland neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000314-38-ITEORTC AISBL/IVZW220