Symptoms and General Pathology

All Conditions

Neoplasms

Pain

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Hypofractionated microradiosurgery using Cyber Knife to the vertebral hemangioma to the total dose of 25 Gy in 5.0 Gy per fraction, 2 or 3 days a week over the period of 2 weeks,

Conventionally fractionated external beam conformal radiotherapy to the vertebral hemangioma to the total dose of 36 Gy in 2.0 Gy per fraction, 5 days a week over the period of 3,5 weeks,

Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks

Cybernetic microradiosurgery

Conventionally fractionated linac based external beam radiation therapy - EBRT, (conformal or dynamic) to the TD of 36 Gy, in 2.0 Gy per fraction 5 days a week over the period of 3.5 weeks)

Conventional radiotherapy

Leszek Miszczyk, MD, PhD

Leszek MIszczyk, MD. PhD

Grzegorz Wozniak, MD PhD

Aleksandra Napieralska, MD

Andrzej Tukiendorf, PhD

MIchał Gola, MD

Michał Kalemba, MD

Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic effect in the tumors of two radiotherapy schedules used for patients suffering from painful vertebral haemangiomas

Hemangiomas are frequent vertebral lesions (12% of the whole human population) but only 1% displays any clinical symptoms . The most common symptom is local pain, usually non responding for non-steroid anti-inflammatory drugs. Radiation therapy usually does not result calcification or the tumor regression, but significantly reduces the pain intensity or eliminates it. Currently, the most common RT schedule is conventional radiotherapy using fraction dose (fd) of 2 Gy delivered to the total dose (TD) varying from36 Gy to 40 Gy. The results in pain reduction achieved after larger total doses are better that led us to use radioablative techniques. This procedure is associated with a probability of better analgesic effect and the good local effect (calcification and / or regression of laesion) with high safety of radiation delivery using tracking based cybernetic microradiosurgery (CyberKnife).

The comparison of two modalities of radiation therapy (conventional \[fd 2 Gy, TD 36 Gy\] and hypofractionated \[fd 5 Gy, TD 25 Gy\]) used for treatment of painful vertebral hemangioma patients will be performed in the phase III randomized study.

80 patients will be enrolled in this study. All patients will be planned (RT) on the base of CT/MRI fusion.

Patients will be controlled 1, 3, 6, 9, 12 months after treatment completion and, next every each 6 months. Pain relief, analgesics uptake, local effect (MRI and Technetium - 99m-labelled RBC(red blood cell) scintigraphy) and eventual toxicity will be checked during follow-up (FU).

CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.

Maria Sklodowska-Curie National Research Institute of Oncology

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Assessment of nutritional status by anthropometry, bioelectrical impedance, blood sampling and application of psychometric hepatic encephalopathy score and critical flicker frequency, to assess the presence of hepatic encephalopathy.

The evaluation will take place over a period of 30 days.

HCC under treatment with radioablation

Aldo Torre Delgadillo, M.D. M.Sc

Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency.

There will be a prospective, longitudinal, comparative. It included 20 patients diagnosed with hepatocellular carcinoma. As there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients.

The duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). Each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF).

Anthropometric measures to be taken are weight, height and arm circumference average.

Bioelectrical impedance will be using a single frequency impedance meter (425 to -50 KHz, Range 0 to 10,000) Bioelectrical Body Composition Analyzer Quantium II RJL Systems. The team measured the subjects' impedance, resistance, reactance and phase angle by Lean Body program provided by the manufacturer.

Hepatic encephalopathy be evaluated by testing PHES and was measured CFF, also also be measured ammonium, tumor necrosis factor, IL-1, IL-6, IL-10, renin angiotensin aldosterone.

Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

Analysis of Body Composition by Bioelectrical Impedance in Patients With Hepatocellular Carcinoma (HCC) Undergoing Treatment Radioablation

Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated mid-arm muscle circumference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelectrical impedance analysis and individual vectors obtained by bioelectrical impedance vector analysis.

Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas	NCT02332408	Hemangioma of V...	Cybernetic micr... Conventional ra...	25 Years - 85 Years	Maria Sklodowska-Curie National Research Institute of Oncology
Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation	NCT01744639	Liver Carcinoma	HCC under treat...	18 Years - 65 Years	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation	NCT01744639	Liver Carcinoma	HCC under treat...	18 Years - 65 Years	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Spots Global Cancer Trial Database for radioablation