Stereotaxic Irradiation of Hepatocellular Carcinoma (CKNO-HEP)

Centre Oscar Lambret

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: Fiducials

Radiation: CyberKnife

Study type

Interventional

Funder types

Other

Identifiers

CKNO-HEP-0703

Details and patient eligibility

About

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

Full description

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

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)