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Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

non-progression part

Outcome Description:

Percentage of non-progression 18 months after treatment, according to RECIST criteria

Outcome Time Frame:

18 months after treatment

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

August 2009

Completion Date:

September 2018

Related Keywords:

  • Hepatocellular Carcinoma
  • liver cancer
  • hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular