Stereotaxic Irradiation of Hepatocellular Carcinoma | NCT01165346

Studies
Stereotaxic Irradiation of Hepatocellular Carcinoma

NCT01165346

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

44Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Fiducials
CyberKnife

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-A01504-51	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2009Actual

Primary Completion Date

Mar 31, 2016Actual

Completion Date

Apr 19, 2018Actual

First Submitted Date

Jul 16, 2010

First Submission Date that Met QC Criteria

Jul 16, 2010

First Posted Date

Jul 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 13, 2026Actual

Name	Class
National Cancer Institute, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stereotaxic radiation by CyberKnife	Experimental	Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days	Radiation: Fiducials Radiation: CyberKnife

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fiducials	Radiation	Implantation of fiducials	Stereotaxic radiation by CyberKnife

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
non-progression part	Percentage of non-progression 18 months after treatment, according to RECIST criteria	Up to 18 months

Secondary Outcomes

Measure	Description	Time Frame
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.	Up to 5 years after treatment
hepatic non progression part

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Xavier MIRABEL, MD	Centre Oscar Lambret	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centre François Baclesse		Caen		14076	France
Centre Oscar LAMBRET

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057918	Fiducial Markers
D016634	Radiosurgery

Ancestor Terms

ID	Term
D012015	Reference Standards
D014894	Weights and Measures
D008919	Investigative Techniques
D019736	Prostheses and Implants

Browse Leaves

Not provided

Browse Branches

Not provided