NCT02847767Unknown不适用
Dynamic Contrast Enhanced Imaging of Patients Receiving SABR for Unresectable or Medically Inoperable Hepatocellular Carcinoma in BC
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Changes in tumour vasculature as assessed by changes PL derived model parameters
研究概览
简要总结
The high dose per fraction (>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy (SABR) has been shown to be more effective at local tumor control than treatments employing more conventional dose fractions. The mechanisms for this are currently under debate. One possible mechanism for this increased effectiveness is that high dose/fraction causes significant vascular damage to the tumor. This study hopes to measure vascular integrity pre and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.
详细描述
Purpose:
The purpose of this study is to determine if high dose per fraction SABR has an impact on the vasculature of both the tumor and of healthy liver tissue.
Hypothesis:
High dose / fraction in HCC patients with tumours < 5 cm will result in detectable changes to kinetic model parameters derived from dynamic contrast enhanced images.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •All the following criteria must be met:
- •Age > 18 years old
- •Multi-phase CT scan and/or MRI of the liver within 8 weeks of radiation planning demonstrating:
- •Liver tumours < 5 cm
- •No more than 2 discrete liver tumours
- •Normal liver > 700 cc
- •Patients must have HCC diagnosed by either: i) pathological confirmation, or ii) intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by one imaging modality if AFP > 200 in the setting of liver cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus guidelines [2])
- •Liver HCC must be deemed unresectable as determined by an experienced hepatobiliary surgeon, or the patient must be medically inoperable or refuse surgery,
- •Patients must be discussed in a multidisciplinary setting, with representatives from Medical Oncology, Radiation Oncology, Surgery, Interventional Radiology, and Hepatology. Patients must be considered ineligible for standard local treatments, including surgery, liver transplantation, radiofrequency ablation, and targeted biologics. Some subjects could be potential candidates for sorafenib but normally this treatment is not considered before all local treatment options have been considered, as the response rate to sorafenib is low (2% in the SHARP study). Patients might be candidates for sorafenib after progression on the study treatment or if they do not want to participate and in both cases they will be referred to a medical oncologist. Patients may have received prior TACE and had an incomplete response. Ineffective or incomplete TACE is defined as incomplete filling by lipiodol-doxorubicin mixture used by either angiography or CT ≥1 month after TACE or by increasing alpha-fetoprotein level. Patients must have recovered from the effects of previous therapies before SBRT with a minimum 4-week period between TACE and SBRT.
- •Eastern Clinical Oncology Group performance status 0, 1, or 2 (Appendix III), or a Karnofsky performance status of ≥ 60 (Appendix IV)
- •Adequate organ function as assessed by the following blood work:
- •Hemoglobin ≥ 90 g/L
- •Absolute neutrophil count ≥ 1.0 bil/L
- •Platelets ≥ 50 bil/L
- •AST and ALT not to exceed 3x upper limit of normal
- •Child-Turcotte-Pugh assessment within 8 weeks of treatment date (Appendix II):
- •Bilirubin ≤ 3 mg/dL (< 50 µmol/L)
- •Albumin above 28 g/L
- •INR < 1.7 and/or correctable with vitamin K (unless on anticoagulation therapy)
- •No ascites or encephalopathy
- •Child-Turcotte-Pugh score must be ≤ 7
- •BCLC Stage B or C (portal venous invasion or liver hilum nodal disease only; (Appendix I)
- •Life expectancy > 6 months
- •No chemotherapy or systemic therapy concurrent with radiotherapy
- •Previous treatment(s) with radiofrequency ablation, surgery, TACE, Y90, percutaneous ethanol injection, or chemotherapy are not exclusion criteria provided that recurrence or lack of tumour response has been documented. Patients who decline, or not eligible for, these treatments will also be considered eligible.
- •Patient signs a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative. A translator will be provided if the patient has a language barrier.
- •Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55
排除标准
- •Patients with active hepatitis, encephalopathy, or ascites related to liver failure
- •Female patients who are pregnant (verify with blood test if patient is pre-menopausal). Pre-menopausal patients may also not become pregnant during participation in this study.
- •Prior external beam radiation to the upper abdomen
- •Patients with distant metastases or extrahepatic nodal progression (patients with portal venous thrombosis and liver hilum nodal involvement remain eligible)
- •Patients who have < 700 cc of normal liver.
- •Child-Turcotte-Pugh scores > 7
- •BCLC Stage A, C (N1 and/or M1), D
- •Prior gastric, duodenal, or variceal bleed within the past 2 months
结局指标
主要结局
Changes in tumour vasculature as assessed by changes PL derived model parameters
时间窗: 1 week after cancer treatment
To quantify changes in tumor vascular support for patients receiving SABR.
次要结局
- Association (correlation) between aggregate QOL scores and PK derived model parameters(1 week after cancer treatment)
研究者
Francois Benard
Scientific Director, Functional Imaging
British Columbia Cancer Agency
研究点 (4)
Loading locations...
相似试验
已完成
早期 1 期
Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer PatientsLiver CancerNCT03891654University of Colorado, Denver3
招募中
不适用
Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/ProgressionOligometastatic DiseaseOligoprogressionToxicity Due to RadiotherapyQuality of LifeNCT05784428Robert Olson598
进行中（未招募）
2 期
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)Metastatic TumorsNCT01446744Lawson Health Research Institute99
招募中
不适用
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)Cervical CancerNCT06394297Fundacao Champalimaud30
撤回
不适用
Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body RadiotherapyNeoplasmsSecondary Malignant NeoplasmNCT05578274Soonchunhyang University Hospital186