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Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

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ClinicalTrials.gov Identifier: NCT01165346
Recruitment Status : Unknown
Verified April 2016 by Centre Oscar Lambret.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2010
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: Fiducials Radiation: CyberKnife Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
Study Start Date : August 2009
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : March 2018

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



Primary Outcome Measures :
  1. non-progression part [ Time Frame: Up to 18 months ]
    Percentage of non-progression 18 months after treatment, according to RECIST criteria


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

  2. hepatic non progression part [ Time Frame: Up to 3, 6, 9, 12 months ]
    Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.

  3. median time without progression [ Time Frame: Up to 5 years after treatment ]

    Time between :

    • Date of inclusion
    • Date of progression

  4. Best response [ Time Frame: Up to 5 years after treatment ]
    determination of the best response of treatment, according to RECIST

  5. tumor evaluation [ Time Frame: Up to 5 years after treatment ]
    According to EASL

  6. Quality of life [ Time Frame: Up to 18 months after treatment ]
    Questionnaire EORTC QLQ-C30 and QLQ-HCC18

  7. Biological response [ Time Frame: Up to 3, 6, 9 months ]
    tumoral marker : Alpha-fetoprotein

  8. Medical costs [ Time Frame: During the first 3 months ]
    micro-costing



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165346


Locations
France
Centre François Baclesse
Caen, France, 14076
Centre Oscar LAMBRET
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69373
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Centre Oscar Lambret
National Cancer Institute, France
Investigators
Principal Investigator: Xavier MIRABEL, MD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01165346     History of Changes
Other Study ID Numbers: CKNO-HEP-0703
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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