Stereotaxic Irradiation of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.

Detailed Description
-----------------
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

Official Title
-----------------
Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Radiation: Fiducials
* Radiation: CyberKnife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria T1-3 N0 M0 With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner) Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic Age >= 18 ans Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion OMS =< 2 Portal thrombosis allowed Portal high blood pressure allowed No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation In case of underlying cirrhosis, only the Child-Pugh A is allowed Life expectancy >= 12 weeks Women must have an active contraception during all the study Patient affiliated to health insurance Patient must sign the consent Exclusion Criteria: T4 Cirrhosis Child B and C Hepatic lesion < 1 cm or > 6 cm 2 hepatic lesions or more Recurrent or metastatic disease Patient already included in another therapeutic trial with an experimental molecule Allergy to gold Pregnant women or susceptible to be pregnant or breastfeeding Unable for medical follow-up (geographic, social or mental reasons)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotaxic radiation by CyberKnife<br>Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days | Radiation: Fiducials<br>* Implantation of fiducials<br>Radiation: CyberKnife<br>* 3 fractions over 8 to 10 days, 15 Gy/fraction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-progression part | Percentage of non-progression 18 months after treatment, according to RECIST criteria | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute and late tolerance | Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria. | Up to 5 years after treatment | 
| hepatic non progression part | Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria. | Up to 3, 6, 9, 12 months | 
| median time without progression | Time between : Date of inclusion Date of progression | Up to 5 years after treatment | 
| Best response | determination of the best response of treatment, according to RECIST | Up to 5 years after treatment | 
| tumor evaluation | According to EASL | Up to 5 years after treatment | 
| Quality of life | Questionnaire EORTC QLQ-C30 and QLQ-HCC18 | Up to 18 months after treatment | 
| Biological response | tumoral marker : Alpha-fetoprotein | Up to 3, 6, 9 months | 
| Medical costs | micro-costing | During the first 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cancer, hepatocellular carcinoma