Hepatocellular Carcinoma
Conditions
Keywords
liver cancer, hepatocellular carcinoma
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
Interventions
RADIATIONFiducials
Implantation of fiducials
RADIATIONCyberKnife
3 fractions over 8 to 10 days, 15 Gy/fraction
Sponsors
Centre Oscar Lambret
National Cancer Institute, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| non-progression part | Up to 18 months | Percentage of non-progression 18 months after treatment, according to RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute and late tolerance | Up to 5 years after treatment | Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria. |
| hepatic non progression part | Up to 3, 6, 9, 12 months | Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria. |
| median time without progression | Up to 5 years after treatment | Time between : * Date of inclusion * Date of progression |
| Best response | Up to 5 years after treatment | determination of the best response of treatment, according to RECIST |
| tumor evaluation | Up to 5 years after treatment | According to EASL |
| Quality of life | Up to 18 months after treatment | Questionnaire EORTC QLQ-C30 and QLQ-HCC18 |
| Biological response | Up to 3, 6, 9 months | tumoral marker : Alpha-fetoprotein |
| Medical costs | During the first 3 months | micro-costing |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORXavier MIRABEL, MD
Centre Oscar Lambret
Outcome results
None listed