Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Radiation: Fiducials; Radiation: CyberKnife

Detailed Description

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Leon Berard
  • Vandœuvre-lès-Nancy, France, 54500
    • Centre Alexis Vautrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotaxic radiation by CyberKnife; Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days	Radiation: Fiducials; Implantation of fiducials; Radiation: CyberKnife; 3 fractions over 8 to 10 days, 15 Gy/fraction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.	Up to 3, 6, 9, 12 months
median time without progression	Time between : Date of inclusion; Date of progression	Up to 5 years after treatment
Best response	determination of the best response of treatment, according to RECIST	Up to 5 years after treatment
tumor evaluation	According to EASL	Up to 5 years after treatment
Quality of life	Questionnaire EORTC QLQ-C30 and QLQ-HCC18	Up to 18 months after treatment
Biological response	tumoral marker : Alpha-fetoprotein	Up to 3, 6, 9 months
Medical costs	micro-costing	During the first 3 months

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: Xavier MIRABEL, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2009
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): April 19, 2018

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimated): July 19, 2010

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; liver cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Equipment and Supplies; Radiation Equipment and Supplies; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Prostheses and Implants; Reference Standards; Weights and Measures; Radiosurgery; Fiducial Markers
• Other Study ID Numbers: CKNO-HEP-0703; 2008-A01504-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO