Clinical trial NCT01165346: Stereotaxic Irradiation of Hepatocellular Carcinoma
Official title: Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
hepatocellular carcinoma
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2010-07-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: non-progression part
timeFrame: Up to 18 months
Secondary outcomes:
measure: acute and late tolerance
timeFrame: Up to 5 years after treatment
measure: hepatic non progression part
timeFrame: Up to 3, 6, 9, 12 months
measure: median time without progression
timeFrame: Up to 5 years after treatment
measure: Best response
timeFrame: Up to 5 years after treatment
measure: tumor evaluation
timeFrame: Up to 5 years after treatment
measure: Quality of life
timeFrame: Up to 18 months after treatment
measure: Biological response
timeFrame: Up to 3, 6, 9 months
measure: Medical costs
timeFrame: During the first 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar LAMBRET
city: Lyon
country: France
facility: Centre Léon Bérard
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Oscar Lambret
name: Xavier MIRABEL, MD
role: PRINCIPAL_INVESTIGATOR
References: