Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Implantation of fiducials
3 fractions over 8 to 10 days, 15 Gy/fraction
Centre François Baclesse
Caen, France
Centre Oscar LAMBRET
Lille, France
Centre Léon Bérard
Lyon, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
non-progression part
Percentage of non-progression 18 months after treatment, according to RECIST criteria
Time frame: Up to 18 months
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.
Time frame: 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.
Time frame: Up to 3, 6, 9, 12 months
median time without progression
Time between : * Date of inclusion * Date of progression
Time frame: Up to 5 years after treatment
Best response
determination of the best response of treatment, according to RECIST
Time frame: Up to 5 years after treatment
tumor evaluation
According to EASL
Time frame: Up to 5 years after treatment
Quality of life
Questionnaire EORTC QLQ-C30 and QLQ-HCC18
Time frame: Up to 18 months after treatment
Biological response
tumoral marker : Alpha-fetoprotein
Time frame: Up to 3, 6, 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical costs
micro-costing
Time frame: During the first 3 months