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Status:

COMPLETED

Stereotaxic Irradiation of Hepatocellular Carcinoma

Lead Sponsor:

Centre Oscar Lambret

Collaborating Sponsors:

National Cancer Institute, France

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

August 31 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 19 2018

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT01165346

Start Date

August 31 2009

End Date

April 19 2018

Last Update

May 14 2019

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Centre François Baclesse

Caen, France, 14076

2

Centre Oscar LAMBRET

Lille, France, 59020

3

Centre Léon Bérard

Lyon, France, 69373

4

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France, 54500