Stereotaxic Irradiation of Hepatocellular Carcinoma
CKNO-HEP
2 other identifiers
interventional
44
1 country
4
Brief Summary
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Aug 2009
Longer than P75 for phase_2 hepatocellular-carcinoma
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2009
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedMarch 13, 2026
March 1, 2026
6.6 years
July 16, 2010
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
non-progression part
Percentage of non-progression 18 months after treatment, according to RECIST criteria
Up to 18 months
Secondary Outcomes (8)
acute and late tolerance
Up to 5 years after treatment
hepatic non progression part
Up to 3, 6, 9, 12 months
median time without progression
Up to 5 years after treatment
Best response
Up to 5 years after treatment
tumor evaluation
Up to 5 years after treatment
- +3 more secondary outcomes
Study Arms (1)
Stereotaxic radiation by CyberKnife
EXPERIMENTALImplantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Cirrhosis Child B and C
- Hepatic lesion \< 1 cm or \> 6 cm
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- National Cancer Institute, Francecollaborator
Study Sites (4)
Centre François Baclesse
Caen, 14076, France
Centre Oscar LAMBRET
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier MIRABEL, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 19, 2010
Study Start
August 31, 2009
Primary Completion
March 31, 2016
Study Completion
April 19, 2018
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share