Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

This study is currently recruiting participants.
Verified July 2013 by Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: July 16, 2010
Last updated: July 30, 2013
Last verified: July 2013

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

Condition Intervention Phase
Hepatocellular Carcinoma
Radiation: Fiducials
Radiation: CyberKnife
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Resource links provided by NLM:

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • non-progression part [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Percentage of non-progression 18 months after treatment, according to RECIST criteria

Secondary Outcome Measures:
  • acute and late tolerance [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: Yes ]
    Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria.

  • hepatic non progression part [ Time Frame: Up to 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.

  • median time without progression [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]

    Time between :

    • Date of inclusion
    • Date of progression

  • Best response [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
    determination of the best response of treatment, according to RECIST

  • tumor evaluation [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
    According to EASL

  • Quality of life [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
    Questionnaire EORTC QLQ-C30 and QLQ-HCC18

  • Biological response [ Time Frame: Up to 3, 6, 9 months ] [ Designated as safety issue: No ]
    tumoral marker : Alpha-fetoprotein

  • Medical costs [ Time Frame: During the first 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Fiducials
    Implantation of fiducials
    Radiation: CyberKnife
    3 fractions over 8 to 10 days, 15 Gy/fraction

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Please refer to this study by its identifier: NCT01165346

Contact: Xavier MIRABEL, MD 03 20 29 55 98
Contact: Yvette VENDEL, CRA 03 20 29 59 40

Centre François Baclesse Recruiting
Caen, France, 14076
Contact: M'VONDO Chje Mabubu, MD    33   
Principal Investigator: M'VONDO Che Mabubu, MD         
Sub-Investigator: STEFAN Dinu, MD         
Sub-Investigator: SILVA Marion, MD         
Sub-Investigator: FLORESCU Carmen, MD         
Centre Oscar LAMBRET Recruiting
Lille, France, 59020
Contact: Xavier MIRABEL, MD    03 20 29 59 18   
Sub-Investigator: Eric LARTIGAU, PhD         
Sub-Investigator: Antoine ADENIS, PhD         
Principal Investigator: Xavier MIRABEL, MD         
Sub-Investigator: DEWAS-VAUTRAVERS Claire, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Christian CARRIE, MD    04 78 78 26 52   
Principal Investigator: Christian CARRIE, MD         
Sub-Investigator: Isabelle MARTEL-LAFAY, MD         
Sub-Investigator: Séverine RACADOT, MD         
Sub-Investigator: Line CLAUDE, MD         
Centre Alexis Vautrin Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Didier PEIFFERT, PhD    03 83 59 84 31   
Sub-Investigator: BECKENDORF Véronique, MD         
Principal Investigator: Didier PEIFFERT, MD ,PhD         
Sub-Investigator: BAUMANN-DIETMANN Anne Sophie, MD         
Sponsors and Collaborators
Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret Identifier: NCT01165346     History of Changes
Other Study ID Numbers: CKNO-HEP-0703
Study First Received: July 16, 2010
Last Updated: July 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
liver cancer
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 17, 2014