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Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01165346
First received: July 16, 2010
Last updated: August 21, 2014
Last verified: August 2014
  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:


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 ]
    micro-costing


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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 François Baclesse Recruiting
Caen, France, 14076
Contact: M'VONDO Chje Mabubu, MD    33 2.31.45.50.20    m.mvondo@baclesse.fr   
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    x-mirabel@o-lambret.fr   
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    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 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         
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
ClinicalTrials.gov Identifier: NCT01165346     History of Changes
Other Study ID Numbers: CKNO-HEP-0703
Study First Received: July 16, 2010
Last Updated: August 21, 2014
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
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014