Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments fiducials, cyberknife
Phase phase 2
Sponsor Centre Oscar Lambret
Collaborator National Cancer Institute, France
Start date August 2009
End date April 2016
Trial size 44 participants
Trial identifier NCT01165346, CKNO-HEP-0703

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
fiducials
Implantation of fiducials
cyberknife
3 fractions over 8 to 10 days, 15 Gy/fraction

Primary Outcomes

Measure
non-progression part
time frame: Up to 18 months

Secondary Outcomes

Measure
acute and late tolerance
time frame: Up to 5 years after treatment
hepatic non progression part
time frame: Up to 3, 6, 9, 12 months
median time without progression
time frame: Up to 5 years after treatment
Best response
time frame: Up to 5 years after treatment
tumor evaluation
time frame: Up to 5 years after treatment
Quality of life
time frame: Up to 18 months after treatment
Biological response
time frame: Up to 3, 6, 9 months
Medical costs
time frame: During the first 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
Principal investigator Xavier MIRABEL, MD
Description Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.