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Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)
This study is currently recruiting participants.
Verified May 2012 by Centre Oscar Lambret

First Received on July 16, 2010.   Last Updated on May 9, 2012   History of Changes
Sponsor: Centre Oscar Lambret
Information provided by (Responsible Party): Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01165346
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • non-progression part [ Time Frame: 18 months after treatment ] [ 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: at 3, 6, 9, 12 months of treatment ] [ 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: At 3, 6, 9 months after treatment ] [ Designated as safety issue: No ]
    tumoral marker : Alpha-fetoprotein

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


Estimated Enrollment: 44
Study Start Date: August 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2013 (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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165346

Contacts
Contact: Xavier MIRABEL, MD 03 20 29 55 98 x-mirabel@o-lambret.fr
Contact: Yvette VENDEL, CRA 03 20 29 59 40 y-vendel@o-lambret.fr

Locations
France
Centre Oscar LAMBRET Recruiting
Lille, France, 59020
Contact: Xavier MIRABEL, MD     03 20 29 59 18     x-mirabel@o-lambret.fr    
Sub-Investigator: Eric LARTIGAU, PhD            
Sub-Investigator: Antoine ADENIS, PhD            
Sub-Investigator: Sophie DOMINGUEZ, MD            
Sub-Investigator: Thomas LACORNERIE            
Sub-Investigator: Thierry SARRAZIN            
Principal Investigator: Xavier MIRABEL, MD            
Sub-Investigator: Sylvain DEWAS, MD            
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Christian CARRIE, MD     04 78 78 26 52     carrie@lyon.fnclcc.fr    
Principal Investigator: Christian CARRIE, MD            
Sub-Investigator: Isabelle MARTEL-LAFAY, MD            
Sub-Investigator: Séverine RACADOT, MD            
Sub-Investigator: Line CLAUDE, MD            
Centre Antoine Lacassagne Recruiting
Nice, France, 06182
Contact: Pierre-Yves BONDIAU, MD     04 92 03 16 51     pierre-yves.bondiau@nice.fnclcc.fr    
Sub-Investigator: Philippe FOLLANA, MD            
Sub-Investigator: Eric FRANCOIS, MD            
Sub-Investigator: Gaëlle ANGELLIER            
Sub-Investigator: Serge MARCIE            
Sub-Investigator: Juliette THARIAT, MD            
Principal Investigator: Pierre-Yves BONDIAU, MD            
Centre Alexis Vautrin Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Didier PEIFFERT, PhD     03 83 59 84 31     d.peiffert@nancy.fnclcc.fr    
Sub-Investigator: BECKENDORF Véronique, MD            
Sub-Investigator: Alain NOEL            
Sub-Investigator: Vincent MARCHESI            
Principal Investigator: Didier PEIFFERT, MD ,PhD            
Sponsors and Collaborators
Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01165346     History of Changes
Other Study ID Numbers: CKNO-HEP-0703
Study First Received: July 16, 2010
Last Updated: May 9, 2012
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Oscar Lambret:
liver cancer
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2012



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