Status:
COMPLETED
Stereotaxic Irradiation of Hepatocellular Carcinoma
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01165346
Start Date
August 31 2009
End Date
April 19 2018
Last Update
May 14 2019
Active Locations (4)
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1
Centre François Baclesse
Caen, France, 14076
2
Centre Oscar LAMBRET
Lille, France, 59020
3
Centre Léon Bérard
Lyon, France, 69373
4
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500