Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2009-08-31
2018-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotaxic radiation by CyberKnife
Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
Fiducials
Implantation of fiducials
CyberKnife
3 fractions over 8 to 10 days, 15 Gy/fraction
Interventions
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Fiducials
Implantation of fiducials
CyberKnife
3 fractions over 8 to 10 days, 15 Gy/fraction
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Xavier MIRABEL, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre François Baclesse
Caen, , France
Centre Oscar LAMBRET
Lille, , France
Centre Léon Bérard
Lyon, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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CKNO-HEP-0703
Identifier Type: -
Identifier Source: org_study_id
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