Hepatocellular CarcinomaPhase 2CKNO-HEPNCT01165346
Stereotaxic Irradiation of Hepatocellular Carcinoma
A Phase 2 study testing Fiducials and CyberKnife in people with Hepatocellular Carcinoma, run by Centre Oscar Lambret at 4 sites in France.
Trial summary
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Fiducials and CyberKnife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesFrance
- Study dates
- 31 Aug 2009to 19 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Allergy to gold
- Pregnant women or susceptible to be pregnant or breastfeeding
- Unable for medical follow-up (geographic, social or mental reasons)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François Baclesse
Caen, 14076
Centre Oscar LAMBRET
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
Read the detailed description
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Fiducials, CyberKnife
- Keywords
- liver cancer, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiducialsRadiation
Implantation of fiducials
CyberKnifeRadiation
3 fractions over 8 to 10 days, 15 Gy/fraction
| Study group | Role | What they receive |
|---|---|---|
| Stereotaxic radiation by CyberKnife | Experimental | Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days Receives: Radiation: Fiducials; Radiation: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-progression part
Percentage of non-progression 18 months after treatment, according to RECIST criteria
Measured: Up to 18 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: Up to 3, 6, 9, 12 months
median time without progression
Time between :
- Date of inclusion
- Date of progression
Measured: Up to 5 years after treatment
Best response
determination of the best response of treatment, according to RECIST
Measured: Up to 5 years after treatment
tumor evaluation
According to EASL
Measured: Up to 5 years after treatment
Quality of life
Questionnaire EORTC QLQ-C30 and QLQ-HCC18
Measured: Up to 18 months after treatment
Biological response
tumoral marker : Alpha-fetoprotein
Measured: Up to 3, 6, 9 months
Medical costs
micro-costing
Measured: During the first 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study start31 Aug 2009
- Primary completion31 Mar 2016
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Xavier MIRABEL, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165346
- Sponsor's protocol ID
- CKNO-HEP-0703
- Other IDs
- 2008-A01504-51
- Acronym
- CKNO-HEP
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2010
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
- ClinicalTrials.gov ID
- NCT01165346
- Acronym / sponsor ID
- CKNO-HEP / CKNO-HEP-0703
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 31 Aug 2009 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotaxic radiation by CyberKnife | Experimental | Radiation: Fiducials, Radiation: CyberKnifeImplantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- T4
- Cirrhosis Child B and C
- Hepatic lesion < 1 cm or > 6 cm
- 2 hepatic lesions or more
- Recurrent or metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiducialsImplantation of fiducials | Radiation | Stereotaxic radiation by CyberKnife |
| CyberKnife3 fractions over 8 to 10 days, 15 Gy/fraction | Radiation | Stereotaxic radiation by CyberKnife |
Primary outcome
non-progression part
Time frame: Up to 18 months
Percentage of non-progression 18 months after treatment, according to RECIST criteria
8 secondary outcomes
acute and late tolerance
Time frame: Up to 5 years after treatment
hepatic non progression part
Time frame: Up to 3, 6, 9, 12 months
median time without progression
Time frame: Up to 5 years after treatment
Best response
Time frame: Up to 5 years after treatment
tumor evaluation
Time frame: Up to 5 years after treatment
Quality of life
Time frame: Up to 18 months after treatment
Biological response
Time frame: Up to 3, 6, 9 months
Medical costs
Time frame: During the first 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier MIRABEL, MD principal investigator
Centre Oscar Lambret
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fiducials and CyberKnife in people with Hepatocellular Carcinoma, run by Centre Oscar Lambret at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-progression part (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.